Explore every episode of the podcast Let's Talk Quality

Colleen Walson-Billin was told she was not eligible to progress in Quality without a science degree, and went on to lead a full GxP Quality function at a biologics startup.

Colleen Walson-Billin on building a Quality career without a science degree.

In today's episode I was joined by Colleen Walson-Billin, Vice President & Head of GxP Quality & Compliance at Jade Biosciences. I wanted to speak to Colleen because her route into Quality started with a business degree and a role as administrative assistant to a director of Quality at Amgen. From there she moved through QA, corporate and international Quality, served twice as chief of staff to the head of Quality, and now leads Quality across GMP, GCP, GLP and pharmacovigilance.

We talk about:

• Starting in Quality as an administrative assistant, and telling her first boss up front that the role was her foot in the door
• Being told she was not eligible to progress without a science degree, and building her technical knowledge on the job
• Serving twice as chief of staff to the head of Quality, and what she learned at the table with the leadership team
• Leaving Amgen for smaller companies, and picking up GCP, GLP and pharmacovigilance for the first time
• Leading executive and senior directors, stepping back from being the doer, and positioning Quality as a partner from the start

Thank you Colleen for sharing your journey.

Timestamps:

(00:00) Introduction

(00:46) "My foot in the door": business degree to admin assistant

(05:02) "You're just not even eligible"

(08:51) The advice that made the degree stop mattering

(12:34) A career with no plan, built by putting her hand up

(19:14) Leaving Amgen for a smaller company

(22:01) Employee number 24, and "enough to be dangerous" across GxP

(25:14) Why the degree becomes almost irrelevant at 20 years

(29:50) Roadblocks, naysayers and the police: old school Quality

(35:06) Selling Quality to a room of college students

(40:03) Inspired by what she did not want to become

Geetu Abbi was handed the GAMP guide as a new validation engineer at Genzyme, and in 2024 she co-led one.

Geetu Abbi on When to Build a Digital Quality Function

In today's episode I was joined by Geetu Abbi, Head of Digital Quality Assurance at Alkermes. I wanted to speak to Geetu because Digital Quality was not a job title eight to ten years ago, and she has grown into the role from computer systems validation. She moved from software testing into validation at Siemens without a life sciences background, and in 2024 she co-led the GAMP guide for GCP and clinical trials.

We talk about:

- Moving from software testing into validation at Siemens, with no prior exposure to Part 11 or 21 CFR 820

- What Digital Quality is, and the gap it fills between site Quality and clinical Quality

- Data lifecycle mapping, and why validation now has to be revisited with every change

- Delivering seven validated systems in eight months to support the Alkermes-Mural Oncology separation in 2023

- Her advice to the next generation of Quality professionals on why they don't have to solve everything alone

Thank you Geetu for sharing your journey.

Timestamps:

(00:00) Introduction and guest background

(03:42) From QA to validation

(08:00) Career turning point

(13:04) What digital quality means

(22:28) Digital quality as a career opportunity

(29:58) How the team is structured

(34:06) Advice for future quality leaders

Naymisha (Isha) Patel has spent thirty years in Quality and regulatory compliance across pharmaceuticals, biologics, medical devices and combination products. She is now Senior Vice President of Quality at AirNexis Therapeutics, a seven-month-old startup developing a combination product for COPD, where she is the first Quality hire.

In this episode Isha talks about the ten-year career plan she wrote overnight in 2005 after a hiring VP at Nektar asked what she wanted, and how it carried her from associate director to senior vice president. She explains why she moved to Boston in a blizzard to lead Quality at Ocular Therapeutix, a one-product company with two FDA complete response letters, and what she found in the inspection scribe notes. She walks through the reorganisation, letting go of people whose skill sets did not match the product classification, and the FDA inspection that ended in approval with no post-approval commitments. Isha also covers building Tenaya's Quality function, closing that same manufacturing facility four and a half years later, and choosing between consultants and permanent headcount.

Topics covered:

- Why a career plan written on paper beats a vague ambition

- Reading the scribe notes, not just the CRL

- Letting people go for skill fit, not performance

- What FDA inspectors want to see when you are not finished

- Green flags when a CEO hires their first head of Quality

- Consultant or permanent hire: the two-year vision test

- Why Quality is missing from early-stage boards

- Quality as navigating grey zones, not yes or no

Timestamps:

(00:00) Introduction and guest background

(02:52) Transitioning into Quality leadership

(06:34) Career moves and a pivotal opportunity

(08:38) A practical career plan

(13:13) Turning around a Quality system

(20:21) Building Quality in gene therapy

(22:14) Choosing the right startup role

(25:42) Building a lean Quality team

(28:09) C-suite and board aspirations

(30:10) Advice for aspiring Quality leaders

Dawn Houlihan started out as the person manufacturing teams went quiet around, and spent the next twenty years proving that quality works better as a partner than a police force.

Dawn Houlihan on Her Journey From Ireland Big Pharma to the Boston Start-Up World

In today's episode I was joined by Dawn Houlihan. I wanted to speak to Dawn because she has built a quality function from nothing, and has done it across almost every stage and modality the industry has to offer. She spent half her career with Janssen in Ireland, moved to Scotland and then to Boston, and has since led quality through phase three, commercial approval and cell and gene therapy in two small companies where everything was outsourced.

We talk about:

• What quality was actually like on the manufacturing floor in Ireland in the mid two thousands
• The mentor who told her to say yes to a project she did not have time for
• Switching CDMO in the middle of phase three and still hitting commercial approval
• Why saying no to everything is the easy road, and what it costs a small company
• Being the first quality hire at Ensoma and building the culture from scratch

Timestamps:

(00:00) Introduction and Dawn's background in pharma

(05:03) Quality's evolution: from policing to partnership

(07:20) Mentorship, Scotland, and the move to Boston

(13:10) Building quality teams in biotech startups

(19:09) Trust, risk, and leading through partnership

(29:29) Building quality from the ground up

(34:16) The future of quality leadership and career advice

Luciana Mansolelli spent twenty years on the sponsor side. One question from a board chairman moved her to a CDMO.

Luciana Mansolelli on her first year as CQO in the CDMO world.

In today’s episode I was joined by Luciana Mansolelli, Chief Quality Officer at Minaris Advanced Therapies. I wanted to speak to Luciana because she has now led quality on both sides of the same relationship - Novartis and J&J on the sponsor side, and now a 200-person global quality organisation across the US, Germany and Japan.

We talk about:

• The moment she realised she had stopped learning, and why she left

• Why framing speed against quality is the wrong model in advanced therapies

• How she structured a global quality team around the science rather than the org chart

• What she assesses for when she hires, beyond technical competence

• Turnover in the CDMO world, and why she thinks capability is the fix

Thank you Luciana for sharing your journey.

Timestamps:

(00:00) Introduction to Luciana Monsolelli

(01:01) Journey into Pharmaceutical Sciences

(02:41) The Evolution of Quality in Pharma

(05:32) Transitioning from Big Pharma to CDMO

(08:30) Challenges in the CDMO Landscape

(14:00) Building a Quality Culture at Minaris

(19:00) Talent Management and Capability Development

(27:00) Leadership Style and Team Dynamics

(37:00) Future Aspirations in Advanced Therapies

Season Four is at its halfway point, so instead of a guest this week I’ve gone back over the conversations so far and pulled out the theme that came up most often.

The quality leader whose main function is to say no is finished.

This episode is four clips from Season Four guests on that theme, with my own thoughts in between.

I also talk about why I think this matters for your career and not just for your working relationships, which comes from the other half of my week, placing quality leaders and hearing what hiring managers are actually asking for.

Get in touch

If you’re going through that step up at the moment, I’d be interested to hear about it. Find me on LinkedIn, or book a conversation here: https://calendly.com/h-ilangaratne/meeting-with-hemish-rx-group

If there’s a topic you’d like covered on a future solo episode, send it over.

Timestamps:

(00:00) - Intro - Halfway Through Season Four

(01:50) - The Old Reputation - Tim Mitchell

(03:30) - Hemish's Take - Reputation vs. Reality

(04:23) - Saying No Is the Easy Option - Kim Garko

(05:51) - Hemish's Take - The Career Angle

(07:21) - Translating Risk for the Business - Jamey Lindholm

(10:02) - Hemish's Take - Practical Application

(10:59) - Partnership Over Policing - Rex Ready

(14:21) - Closing Thoughts - What This Means for Quality Leaders

Quality culture isn't built by SOPs. It's built in the small moments when a leader reinforces the right behaviour or lets the wrong one slide.

Speaking the Language of the Business, with Jamey Lindholm.

In today's episode I was joined by Jamey Lindholm, Vice President of Quality at R1 Therapeutics. I really wanted to speak to Jamey because she has led Quality through nearly every stage a career in this industry can throw at you: a first-in-class FDA approval at Seres Therapeutics, an acquisition by Merck KGaA at Springworks, and now building a Quality function completely from zero as R1's very first Quality hire. She has strong, hard-won views on how to get each of those right.

Jamey's journey started almost by accident. She fell into a QC chemistry job at a small biotech straight out of university, got laid off a year later when the company ran out of funding, and then spent the next 20 years at Biogen, where she built the foundation of what she now calls "what good looks like" in Quality. From there she moved to Seres Therapeutics, where she led end to end Quality through the first FDA approval of a microbiome-derived oral therapy, then to Springworks through its acquisition by Merck KGaA, and now to R1 Therapeutics as its first Quality hire.

What comes through across the whole conversation is a leader who has thought deeply about the difference between compliance and culture. Jamey is clear that Quality earns its seat at the leadership table not by enforcing SOPs, but by translating compliance into risk, into regulatory consequence, into business decisions that leadership teams actually understand. She is equally clear that the industry has a visibility problem. Almost nobody chooses Quality as a career at school, and she believes that is something the industry has an obligation to fix.

We talk about the following:

• Why 20 years at a large pharma company can make the move into a startup harder, not easier
• The difference between managing Quality operations and being responsible for end-to-end Quality at a small company
• Why "quality risks are business risks" changes how a leadership team makes decisions
• What actually builds quality culture, and why it isn't SOPs
• The moment Seres received FDA approval for Vowst, and why it felt different from anything Jamey experienced at Biogen
• Why it's never too early to bring in a permanent Head of Quality, and what that decision signals about a company's culture
• Why Quality is invisible as a career choice to STEM students, and what the industry can do about it

Jamey is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Jamey for sharing your incredible journey. Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR

• A Head of Quality or VP Quality building a function from scratch at a startup
• A big pharma quality professional considering a move into biotech
• A founder or CEO deciding when to bring in a permanent Head of Quality
• A quality manager trying to build genuine culture, not just documentation
• A STEM student or early-career scientist who has never considered Quality as a career path

Timestamps:

(00:00) Introduction to Jamey Lindholm and Her Career Journey

(02:41) Transitioning from Big Pharma to Startups

(05:14) Navigating Quality in Complex Environments

(07:38) The Role of Quality in Business Strategy

(10:16) Building a Quality Culture in Startups

(13:14) Hiring for Quality in Startups

(15:42) The Visibility of Quality Careers in STEM

(18:29) Demystifying Quality for Future Generations

(21:12) Inspiring the Next Generation in Quality Science

(22:40) The Emotional Impact of FDA Approvals

(26:46) The Importance of Quality Leadership in Startups

(31:30) Building a Quality Culture from the Ground Up

(34:50) Advice for Future Quality Professionals

(37:03) Making the Case for a Career in Quality

Twenty years at Merck, then a leap into academia and psychedelic medicine - here is how Dawn Lundin built a quality career on instinct.

Dawn Lundin on the big pharma habits you have to unlearn in a startup.

In today's episode I was joined by Dawn Lundin, founder of her own quality consultancy and a fractional Head of Quality across biotech and psychedelic-medicine companies. I really wanted to speak to Dawn because her path is nothing like the typical quality leader's. She didn't stay inside big pharma and climb one ladder. She spent twenty years at Merck, then walked into academia, then into one of the most stigmatised fields in medicine, and she made each move work.

Dawn started as a bench chemist and grew through GLP, clinical packaging, GCP auditing and pharmacovigilance, eventually heading up issues management and co-authoring the first quality manual for Merck's research division. Then, on the morning of her twentieth anniversary, she resigned. She moved to the University of Pennsylvania to build fit for purpose quality systems for both sponsor and site research, a system still in use today. From there she stepped into psychedelic medicine for mental health, a move driven as much by personal loss as by professional curiosity.

What runs through Dawn's whole story is a refusal to lead by importing an old playbook. In a smaller, faster environment she learned to do quality with far less, to put relationships before procedures, and to build trust before she changed a single thing. Her line for it has stuck with me: she did quality "one cup of coffee at a time."

We talk about the following:

• Why she left twenty years at Merck on the exact morning of her anniversary
• The big pharma habits leaders have to unlearn in academia and startups
• How to build a fit for purpose quality system with a fraction of the resources
• Why relationships, not procedures, carry a quality programme in a small organisation
• The personal story that drew her into psychedelic medicine and mental health

Dawn Lundin is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Dawn for sharing your incredible journey. Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR

• Quality leaders moving from big pharma into a startup, scale-up or academia
• Hiring managers building a first quality team and weighing up big pharma candidates
• Early-stage biotech founders who need fit for purpose quality without the overhead
• Quality professionals weighing a bold or unconventional career move
• Anyone drawn to how mental health and psychedelic medicine are being built responsibly

Timestamps:

(00:00) - Introduction to Dawn Lundin

(01:15) - Dawn's Journey into Science and Quality

(05:05) - Career Growth at Merck

(11:16) - Transitioning from Big Pharma to Academia

(17:34) - Navigating Startup Challenges

(22:54) - Current Consultancy and Future Aspirations

Forty seven years in quality, and Tim Mitchell says the job he started is nothing like the one he does today.

Tim Mitchell on how quality stopped being black and white

In today's episode I was joined by Tim Mitchell, Vice President of Quality at Aktis Oncology, a radiopharmaceutical company in Boston developing treatments across several types of cancer. I really wanted to speak to Tim because very few people have watched quality evolve the way he has. He started in 1980, when the GMP regulations were barely a year and a half old and a quality assurance function did not really exist yet.

Tim's story begins in a loud, industrial antibiotic fermentation plant, monitoring sixty to ninety thousand gallon fermenters that ran into the ground. His father worked in the neighbouring department at Eli Lilly, and an internship near his hometown turned into fourteen years at Lilly and a career that carried him from big pharma through to the start-up world he works in now. Along the way he moved from manufacturing into a validation team, without knowing what validation even was, and found that quality suited him.

What comes through most is his view of the role itself. Tim does not see quality as a police force. He sees it as a collaborative partner to the rest of the business, a role that demands technical depth, patience and judgement. He talks openly about how the work has moved from black and white rule-following to something far more gray, especially in early-stage biotech where the science is moving faster than the rulebook.

We talk about the following:

• How the quality function grew from a paperwork desk job into a value-adding partnership
• Why some of the best quality people come from manufacturing backgrounds
• The case for learning proper GMP systems in big pharma before joining a start-up
• What good mentoring actually looks like, and why annual reviews are not enough
• How the relationship between the FDA and biotech is becoming genuinely collaborative

Tim Mitchell is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. Thank you Tim for sharing your incredible journey. Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR

• Quality professionals moving from big pharma into a clinical-stage biotech
• Managers building or scaling a quality management system from scratch
• Manufacturing and technical operations people considering a move into quality
• VPs and Directors of Quality thinking about how they mentor their teams
• Anyone early in their quality career trying to understand where the role is heading

Timestamps:

(00:00) Introduction to Tim Mitchell and His Journey

(02:27) Evolution of Quality in the Pharmaceutical Industry

(05:07) The Changing Landscape of Quality Roles

(07:59) Skills for Modern Quality Professionals

(10:29) Mentorship and Team Development

(13:16) The Future of Quality Leadership

(16:20) Navigating the Transition from R&D to Commercialization

(19:01) The Role of Quality in Biotech Innovation

(21:12) Challenges and Opportunities in Quality Management

(24:38) The Importance of Collaboration in Quality

(27:07) Advice for Aspiring Quality Leaders

She came to the US with her first year's tuition and figured the rest out from there. What followed is one of the most grounded quality leadership journeys I have heard - and one we felt was worth bringing back.

Swetha Krishnan on Building a Quality Mindset from the Ground Up

This is a rerelease of one of our favourite episodes from two years ago. In today's episode I was joined by Swetha Krishnan. I really wanted to bring this conversation back because Swetha's route into quality was entirely unplanned - and the way she has turned that unplanned start into a clear leadership philosophy is something every quality professional should hear.

Swetha came to the US from India to complete a master’s in bioengineering at the University of Toledo. She needed work, she needed a visa sponsor, and she found her way into a contractor role at Pfizer in Connecticut doing technical writing and validation. It was not the destination she had mapped out, but two years of being moved from role to role - quality management systems, regulatory content authoring, client-facing support - gave her a cross-functional view of how a pharma company actually operates. From there she moved through roles at Biogen, Sanofi Genzyme, and Alkermes before taking on her current position leading quality across all GXPs at Mural Oncology, a clinical-stage biotech focused on cytokine-based immunotherapies for cancer.

Swetha leads with a combination of strategic clarity and genuine warmth. She is honest about the things she struggled with early on - particularly the belief that credibility required having all the answers - and equally clear about what changed that. She talks about the boss at Alkermes who told her she would one day be head of quality before she believed it herself, the nine-month Women Unlimited LEAD program that gave her two external mentors, and the MIT Leadership

Signature course that asked her to examine what in her personal history shapes how she shows up every day.

We talk about the following:

• How a bioengineering thesis on non-invasive glucose measurement for diabetics led to an unexpected start in quality

• Starting as a contractor at Pfizer and what wearing so many hats in two years taught her about the whole product life cycle

• Why validation gave her a quality mindset before she had ever formally joined a quality team

• The shift from individual contributor to manager to leader of teams - and why it forced her to rethink everything she thought she knew about credibility

• The nine-month Women Unlimited LEAD program at Alkermes and the boss who saw her potential before she saw it herself

• Quality by design in practice - being involved in CRO selection from the start, not after the contract is signed

• How she manages prioritisation, managing up, and keeping her team grounded in a lean, fast-moving clinical-stage biotech

• Her 4C model for aspiring quality leaders: challenge, curiosity, collaboration, and compassion

Swetha is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you. You can watch on LinkedIn Live at 12pm EST today or listen via Apple or Spotify. Thank you Swetha for sharing your incredible journey. Hope everyone enjoys the show.

Who This Episode Is For

• Quality managers and directors in clinical-stage biotech who are building systems and leading teams without large headcounts or unlimited budgets

• Aspiring heads of quality who are in the transition from individual contributor to people leader and finding that shift harder than they expected

• Quality professionals who came into the function from validation, technical writing, or another non-traditional route and are still making sense of how it all connects

• Senior quality leaders who want a practical framework for developing the next generation on their team

• Anyone in pharma or biotech who has ever felt like asking for help put their credibility at risk

Timestamps:

(00:00) Introduction to Swetha Krishnan and Mural Oncology

(05:08) The Importance of Quality in Biotech

(11:00) The Role of Quality in Driving Strategy

(16:39) Managing Stress and Prioritization

(21:55) Self-Development and Continuous Learning

(26:44) Advice for Aspiring Quality Leaders

What does it really take to build a quality organization from the ground up - and do it again, and again, across multiple companies? Laura Singer on building quality that scales.

In today's episode I was joined by Laura Singer, Vice President of Quality and Compliance at Loyal. I really wanted to speak to Laura because she has spent the better part of two decades walking into an early-stage biotech and building everything from scratch. Each time, a different product, a different regulatory landscape, a different team. And each time, the same fundamental challenge: how do you build quality infrastructure that is fit for today, but will not break tomorrow?

Laura's career is a study in what it means to grow as a quality leader. She started in quality systems, realized she wanted more breadth, and made a deliberate move into a full GXP leadership role at Amicus as VP of Quality - a company that was developing its first commercial product for a rare disease. She came in as a senior director, proved herself, and earned the VP title. From there she spent six years at Heron Therapeutics building out an international quality function, and has since continued that pattern in successive roles.

What makes Laura a compelling guest is not just the technical expertise - it is her philosophy. She talks about quality not as a compliance function, but as a business partner. She talks about leadership not as direction-giving, but as creating the conditions for other people to own their work. And she talks about the job of a quality head at the executive level with unusual clarity: you walk in with a plan, you are calm, you translate the regulations for the people around you, and you do not retreat when things go wrong.

We talk about the following:

• What it means to find your niche as a quality leader and how Laura discovered hers

• Making the leap from a specialist quality systems role to a full GxP VP position without a network inside the company

• How to communicate with a C-suite and executive team as a quality leader - and where most people get it wrong

• What actually breaks in a quality system when a company scales from 40 to 140 people

• How to define inspection readiness in practice, including the CDMO piece that often gets underestimated

• Leadership philosophy, hiring for fit, and the importance of executive presence in quality

Laura is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments. If you are a quality

professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.

Thank you Laura for sharing your incredible journey. Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR

• Quality leaders at VP and SVP level who are navigating the transition from compliance-focused to business-aligned quality leadership

• Heads of Quality at early-stage biotechs who are building or scaling their quality function for the first time

• Senior Directors and Directors of Quality who are ready to make the step up to VP and want to understand what that leap really looks like

• Quality professionals at any level who want to build stronger relationships with their C-suite and executive team

• Anyone in the life sciences who wants to understand what good quality leadership actually looks like in practice

Timestamps:

(00:00) Introduction to Laura Singer's Career Journey

(05:47) Navigating Organizational Challenges

(08:55) Effective Communication with Executives

(12:06) Scaling Quality Systems in Organizations

(17:34) Leadership Philosophy and Team Building

(20:47) Managing Upwards and Sideways

(24:26) Future Aspirations and Career Advice

From the lab bench to the C-Suite - and every crisis in between.

In today's episode I was joined by Kimberly Garko, former Senior Vice President and Chief Technical Officer at Akebia Therapeutics.

I really wanted to speak to Kim because her career trajectory is unlike almost anyone else I have interviewed on this show. She is a PhD virologist who began her career in the QC lab at Biogen, and over the following two decades built herself into one of the most accomplished quality and technical operations executives in the industry. She has led through warning letters, product recalls, complete response letters, workforce reductions, and commercial drug launches - often all at the same organisation. Her story is one of relentless curiosity, self-belief, and a genuine commitment to the patient at every stage.

Kim talks about the pivotal moment early in her Biogen career when she was pulled out of the lab to help lead the effort to return Tysabri to market following its voluntary withdrawal. She discusses how that experience raised her ceiling permanently, and why she has never been able to go back to a smaller version of herself since. She shares how she thinks about building quality culture, identifying real leaders within an organisation, and what it actually takes to lead a team through a product recall at 3am on a Tuesday.

We talk about the following:

• How a JC virus safety crisis at Biogen changed the entire direction of Kim's career

• What she looks for when she joins a new organisation and how she scales quality teams without losing culture

• Her philosophy on 'creative compliance' and why the answer in quality is never just no

• How to lead through warning letters, product recalls, and complete response letters without losing the team

• The knowledge management crisis that follows every reduction in force and why most organisations are not prepared

• What the Vafseo launch felt like after everything Akebia had been through

• Her advice to quality leaders who want to reach the C-Suite

Kimberly Garko is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in the most complex development environments imaginable. She has done this across biologics, oral solid dose, devices, and combination products at every stage from early clinical through to commercial launch.

If you are a quality professional at any stage of your career - whether you are building your first team or trying to figure out what comes after VP - this episode is for you.

Thank you Kim for sharing your incredible journey.

Hope everyone enjoys the show.

WHO THIS EPISODE IS FOR:

• Quality leaders at director and VP level who are navigating high-pressure compliance situations and want a practical framework for crisis response

• Aspiring quality executives who want to understand what it actually takes to move from functional leader to Chief Technical Officer

• Quality managers in biologics, pharma, and biotech who want to build stronger, more resilient teams

• Anyone who has ever had to manage a recall, a warning letter, or a workforce reduction and wants to hear from someone who has been through all three

• Early-career scientists and QC professionals wondering whether there is a path to leadership from the lab bench

Timestamps:

(00:00) Introduction and Origin Story

(03:41) The Tysabri Crisis and What It Built

(09:48) Leadership Philosophy: People, Culture, and Scaling Quality

(17:34) Turnarounds, Recalls, and Crisis Leadership

(29:55) The Human Side: Celebration, Female Leadership, and Career Advice

Three BLAs. Three companies. One industry-defining challenge.

In this special compiled episode of Let's Talk Quality, Hemish Ilangaratne brings together three quality leaders who have each led their organisation through one of the most demanding transitions in the industry: from clinical development to commercial manufacturing for a cell or gene therapy product.

Jake Trees spent five years at Bristol Myers Squibb leading the quality function through the approval and launch of Abecma and Breyanzi, two of the first commercially approved CAR T cell therapies in the world.

Irving Ford was the first quality hire at the Celgene cell therapy facility in New Jersey, built the QC organisation from nothing, and has since led quality through four BLA approvals across multiple cell therapy companies, most recently at Adaptimmune for the approval of Aucatzyl.

Megan Callan is VP of Quality at Abeona Therapeutics, where she guided the quality team through the FDA approval of Zevaskyn, the first ever approved topical gene therapy for a rare genetic skin disorder.

These are three distinct products, three distinct companies, and three distinct leadership journeys. But across all three conversations, the same themes surface: what it takes to build a quality team from scratch, how to shift the mindset of a clinical organisation towards commercial standards, and what the moment of approval actually feels like after years of sustained effort.

In this episode, you will hear the following:

• Jake Trees on the setbacks on the road to BLA approval, including a refusal to file, cell growth failures during scale-up, and leading through a pandemic while hosting three health authority inspections
• Irving Ford on being the first quality hire at a new commercial cell therapy facility, building a team that grew to over 200 people, and why working in the gray is not a compromise but a core competency in this field
• Megan Callan on taking a quality team from five people to more than 60, coaching a clinical workforce into a commercial mindset, and what it means to empower people to make fast decisions when the patient is waiting

This episode is for anyone who is working towards a first commercial approval, scaling a quality function in cell or gene therapy, or trying to understand what it takes to lead through the most demanding regulatory and operational environment in modern pharma.

Thank you to Jake, Irving, and Megan for sharing their journeys.

Hope everyone enjoys the show.

The non-linear path is often the most powerful one.

Cinta Burgos on Building a Career Across Functions, Modalities, and Mindsets.

In today's episode I was joined by Cinta Burgos, Senior Vice President of Quality and Regulatory CMC at New Amsterdam Pharma.

I really wanted to speak to Cinta because her career does not follow the path you might expect for someone at SVP level. She has moved across pharma, medical devices, and biologics, held roles in quality engineering, validation, regulatory, and consulting, and built her executive presence not through a linear climb but through curiosity, flexibility, and a willingness to take opportunities as they came.

Cinta's journey began with a biophysics degree, a near-completed master's in mechanical engineering, and early laboratory work on human growth factors and the varicella zoster vaccine. Life changed direction more than once - moving across the country, starting a family, building a consulting practice that spanned 17 years - and through each transition, she added a new dimension to her expertise. Today she leads quality assurance, quality control, quality systems, and CMC regulatory at a company she describes as scientifically driven, ethically led, and genuinely exciting.

What stands out about Cinta is her philosophy of leadership. She talks about moving from task-oriented thinking to big-picture ownership, about not micromanaging the talented people around you, and about the importance of keeping a personal board of directors - mentors you check in with at different stages of your career. She is also candid about the moments where she did not immediately see an opportunity for what it was, and honest about what that taught her.

We talk about the following:

- How a biophysics background and an unfinished master's became an asset in a 30-year career

- Why Cinta moved from R&D to validation to quality and what each transition taught her

- The value of 17 years in consulting and the leadership jump it created

- How quality professionals can move from task-oriented contributors to big-picture leaders

- The role of AI in quality and manufacturing, and why human oversight is non-negotiable

- Why quality voices are still largely absent from board-level conversations

- What it means to treat everyone in your company as a quality professional

Cinta Burgos is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.

If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.

Thank you Cinta for sharing your incredible journey.

Hope everyone enjoys the show.

Timestamps:

(00:00) Cinta's Background and Career Start

(03:14) Career Path: Pharma, Devices, and Biologics

(06:02) Moving Across Functions: R&D, Validation, Quality

(10:59) The Value of Cross-Functional Skills

(14:17) Industry Collaboration and Remote Work

(20:26) Future of Quality at the Board Level

(22:55) AI in Pharma and Manufacturing

(25:20) Advice for Aspiring Quality Leaders

From a graveyard shift in a generic drug lab to leading quality for one of the most advanced cell therapy programs on the planet - Mike Ruane's story is one every quality professional needs to hear.

In today's episode I was joined by Mike Ruane, Head of Quality for In Vivo CAR-T at Bristol Myers Squibb.

I really wanted to speak to Mike because his career is one of the more fascinating journeys I have come across in quality leadership. He has spent nearly two decades within what is effectively the same organisation, yet has lived through multiple acquisitions, spin-offs and complete pivots in therapeutic modality - each time emerging in a stronger, more interesting role than before.

Mike began his career at APP Pharmaceuticals on a midnight QC shift, testing in-process samples on a graveyard schedule. From there, he followed the Abraxane asset into aBraxis Bioscience, built out supplier quality relationships across Central and South America, and eventually relocated from Chicago to New Jersey when Celgene consolidated its operations.

That move opened the door to something entirely new - a CAR-T therapy program called BB2121 - a field Mike had never worked in and knew little about. Eight years later, he is now heading quality for in vivo CAR-T, one of the most cutting-edge modalities in all of biopharma.

What makes Mike Ruane such a compelling guest is not just the breadth of his experience but his philosophy. He is a first-principles thinker who has thrived precisely because he never assumed the existing process was the right one. He asks the uncomfortable questions, encourages his team to do the same, and believes deeply that curiosity is the most underrated skill in quality.

We talk about the following:

How working in a lean generic drug environment early in his career shaped his mindset forever

Navigating multiple acquisitions and spin-offs within a single career arc

What it takes to step into an entirely new therapeutic modality with no prior experience

Why curiosity and asking the right questions is the real engine of career growth in quality

How he interviews candidates and what most people get wrong when they are being interviewed

Mike Ruane is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.

If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.

Thank you Mike Ruane for sharing your incredible journey.

Hope everyone enjoys the show.

Timestamps:

(00:00) Introduction to Mike's Career Journey

(02:01) Transitioning Through Acquisitions and Roles

(06:39) Navigating Supplier Quality and External Partnerships

(11:05) The Shift to CAR T Therapy

(16:05) The Importance of Asking Questions

(20:48) Advice for Future Generations

CAR-T Saved Her Life. Why Can’t Most Patients Access It?

In today’s episode I was joined by Laurie Adami, cancer survivor, patient advocate, and one of the most impactful voices I’ve had on the podcast.

I first spoke to Laurie a couple of years ago, and her episode is still one of the most listened to we’ve had.

Laurie went through a 12-year cancer journey, six lines of therapy, multiple relapses, clinical trials… and ultimately, in 2018, her 7th treatment, CAR T-cell therapy which saved her life and finally for the first time in 12 years put her in a complete remission.

Now, two years on, she’s back.

Still in a complete remission and requiring no further treatment nearly 8 years post CAR T infusion, Laurie is now considered cured even though her cancer is still labeled incurable.

But what stood out to me in this conversation is that while the science has progressed… many of the systemic challenges patients face haven’t.

We talk about the following:

· What life actually looks like after being “cured” of cancer

· The long-term side effects of 12 years of treatment

· Why most biotech and pharma professionals have never spoken to a patient

· The reality behind “patient centricity” in the industry

· Why 80% of eligible patients still can’t access CAR-T therapy

· The biggest bottlenecks in access - awareness and insurance

· The financial burden of cancer treatment in the US

· Where real progress is being made in cell and gene therapy

· The future of CAR-T in autoimmune diseases and beyond

· Laurie’s memoir and why every biotech employee should read it

This is an honest conversation about the gap between scientific progress and real-world patient impact.

A huge thank you to Laurie for returning to the show and tell her story again! The work she is doing to help raise awareness is inspiring, and I’d urge anyone to connect with Laurie and follow her journey.

If you work in biotech, pharma, healthcare, or you’d like to learn more about the challenges this industry still faces… this is one you need to hear.

Timestamps:

(00:00) A Journey of Survival and Remission

(02:28) Life After CAR-T: Misconceptions and Realities

(05:35) The Ongoing Battle: Side Effects and Daily Life

(08:30) Patient Advocacy: Bridging the Gap with Pharma

(11:00) The Disconnect: Patient Needs vs. Industry Understanding

(13:48) Access and Awareness: The Challenges of CAR-T Therapy

(16:36) The Future of CAR-T: Innovations and Progress

(19:30) Writing a Memoir: Sharing the Patient Experience

Perseverance, perspective and people-first leadership in a global quality role.

In today's episode I was joined by Burak Begen, Head of Global Manufacturing Quality at Siemens Healthineers.

I really wanted to speak to Burak because he’s built his career across multiple countries, cultures and challenges, and now leads quality across global manufacturing sites. His journey gives a very real view of what it actually takes to operate at that level.

Burak’s career hasn’t been linear or easy. From starting his career in Turkey, moving to the US for his PhD, rebuilding his career from scratch, and navigating setbacks like job losses and site closures - his story is defined by perseverance and resilience.

What stood out is how those experiences shaped the way he leads today. He leads from the front, sets high standards, but always stays close to his teams. Whether it’s staying late to close records or travelling globally to connect with people on site, his leadership is grounded in accountability and support.

We talk about the following:

• Why perseverance is a defining trait for quality leaders
• Leading global teams across time zones and cultures
• Building a partnership mindset in quality instead of a “policing” approach
• Creating the right KPI culture and avoiding “watermelon metrics”
• Empowering teams to make decisions and building psychological safety

If you are a quality professional managing multiple sites a leader struggling with KPIs, culture or engagement across sites, or someone who wants to step into a larger global role, then this episode is for you.

Thank you Burak for sharing your incredible journey.

Hope everyone enjoys the show.

Timestamps:

(00:00) Introduction to Burak Begen

(06:00) The Importance of Quality in Leadership

(10:39) Cultural Influences on Leadership

(16:11) Navigating Time Zones and Cultural Differences

(21:03) The Role of KPIs in Quality Management

(27:51) Looking Ahead: Future Aspirations

Great quality leaders don’t just build systems - they build people, culture and confidence.

In today's episode I was joined by Melodie Bryce, Chief Quality Officer at Kincell Bio.

Melodie’s journey is a brilliant example of how diverse experience across manufacturing, supply chain, training and quality can shape a well-rounded quality leader

What stood out most is her approach to leadership. Melodie focuses heavily on building strong teams, developing future leaders and creating an environment where people are supported but also expected to take ownership. She combines high standards with a genuine commitment to coaching and mentorship.

We talk about the following:

· How to assess a quality organisation when you first join

· Why hiring “stronger than you” is critical to building high-performing teams

· What makes a great quality leader in fast-growing biotech environments

· The importance of being a self-starter in quality roles

· How to develop future leaders through coaching and mentorship

· What to look for in the first two weeks of hiring someone

· Leading through remediation and why it accelerates growth

· Building a quality culture where everyone takes ownership

· Balancing compliance with real-world decision making in cell therapy

· Why “digging deep” is the foundation of leadership success

Melodie is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.

If you are a quality leader looking to develop stronger teams and future leaders, then this episode is for you.

Thank you Melodie for sharing your incredible journey.

Hope everyone enjoys the show.

Timestamp:

(00:00) Introduction to Quality Leadership

(04:01) Challenges in Quality Leadership

(06:15) Developing Future Leaders

(08:33) Hiring for Success

(11:01) Assessing New Hires

(13:57) Leadership Evolution

(16:04) Cultural Insights in Quality

(18:56) Advice for Aspiring Leaders

If you are the first quality hire in a startup, your job is not to build everything at once.

Your job is to build the right things first.

That was one of the clearest takeaways from my conversation with Rex Ready on Let’s Talk Quality.

A few practical points he shared stood out:

· Follow the path of the product

· Understand the patient experience

· Focus first on what directly affects patient safety

· Build procedures around processes that already work

· Prioritise quality investment based on stage, modality, and risk

In early-phase environments, it is easy to create a long list of things you would like to have.

An EQMS.

A fuller audit programme.

More formal vendor oversight.

A bigger team.

All of that matters.

But not all of it matters equally on day one.

Strong quality leadership is about judgment. It is about knowing what must be in place now, what can come next, and how to build trust while you do it.

That is especially true in cell and gene therapy, where complexity is high and patient impact is immediate.

A very strong conversation with Rex, and a useful one for anyone building quality in a lean biotech environment.

Timestamps:

(00:00) Introduction

(02:30) From Funeral Director to Biotech: A Unique Path

(05:47) Early Experiences in Quality Control

(07:26) Leadership in Quality: Building Relationships

(09:57) Vision for the Future: Drug Development and Quality

(15:04) Building Effective Relationships in Quality

(17:59) Prioritizing Quality in a Lean Team

(22:58) Planning for Future Growth in Quality

(28:01) Reflections on Cell and Gene Therapy

Quality is changing. The systems are getting smarter, the data is getting bigger, and the people side is still the hardest part.

This week, I sit down with Dennis Rodman, Senior Director of Quality Management Systems and Digital Compliance at Intellia Therapeutics.

Dennis brings a rare perspective to quality. With 13 years at BMS across operations, technical services, and quality, he now helps a gene editing company prepare for its first commercial product.

In this episode, we explore:

• Why quality should be value-add, not a compliance hammer
• What separates companies that get digital transformation right from those that don't
• How to choose the right QMS without getting sold something you don't need
• Why AI isn't delivering the ROI people expected, and what's going wrong
• How to manage change when most people don't want it
• What early-career quality professionals should be doing right now to accelerate

A practical, honest conversation for anyone working at the intersection of quality, systems, and people.

Timestamps:

(00:00) Introduction and Background

(05:04) Quality Management Systems and Operations

(09:59) Stakeholder Engagement and Change Management

(15:12) The Role of IT in Quality Management

(21:02) Cultural Shifts and Data Sharing

(23:34) Advice for Aspiring Quality Leaders

(26:01) Future of Biotech and Quality Management

From accidental quality professional to global quality leader - Valerie Brown's story is one of courage, curiosity, and conviction.

In today's episode I was joined by Valerie Brown, Head of Global Quality Assurance and Compliance at Thermo Fisher Scientific's Clinical Research Group.

I really wanted to speak to Valerie because she brings something different to the quality leadership conversation. Yes, she has held senior quality roles across innovator companies, CDMOs, and now one of the largest CROs in the world. But what makes her story compelling is how she got there - and what she learned along the way.

Valerie didn't plan to work in quality. At 22, she was asked to be a scribe for an FDA inspection. The host fell ill on the day. She stepped in - no preparation, no safety net - and handled it.

Someone told her she had a knack for it. She wasn't sure she agreed. She still wanted to be in the lab, in manufacturing, doing what she knew. But that moment planted a seed.

What followed was a career that took her across CDMOs, innovator companies including Gilead Sciences, and now Thermo Fisher - where she leads global quality assurance and compliance for the clinical research group. She has sat on both sides of the table, as sponsor and as service provider, and that experience shapes everything about how she leads.

We talk about the following:

• How Valerie accidentally became a quality professional, and why that unplanned start shaped everything that followed
• What it felt like to host an FDA inspection at 22, with no preparation and no safety net
• Her philosophy of servant leadership and what it really means to lead with empathy in a regulated environment
• The challenge of transforming a fragmented quality organisation into a connected, strategic function at Thermo Fisher
• The difference between working on the innovator side versus the CRO side - and the unique skill set the latter demands
• Why speed and quality are not in conflict, and how embedding quality by design from the outset actually accelerates delivery
• Her approach to talent development - why she prefers to grow leaders from within and how she identifies that potential early
• The growing importance of AI and digital governance in regulated environments, and why quality professionals need to engage with these tools now
• What keeps her up at night heading into 2026 - from talent gaps to trial complexity to the pace of regulatory change
• The advice she would give her younger self, and what she believes every aspiring quality leader needs to understand

Valerie Brown is a highly accomplished global quality leader whose career is a masterclass in adaptability, influence, and patient-centric thinking. She leads with purpose, develops people with intention, and approaches every challenge with the mindset of a problem solver - exactly the kind of leader our industry needs more of.

Thank you Valerie for sharing your incredible journey. Hope everyone enjoys the show!

Timestamps:

(00:00) Introduction to Valerie Brown and Her Journey

(02:59) Valerie's Leadership Philosophy and Style

(06:00) Transitioning from Innovator to CRO: Insights and Challenges

(11:04) Quality Assurance in Clinical Research: A New Perspective

(13:58) Building a Quality Organization: Strategies and Goals

(20:55) The Role of AI in Quality Management

(24:18) Future Goals and Challenges in Quality Assurance

(29:04) Advice for Aspiring Quality Leaders

What if the leader you become is shaped less by your title, and more by the life you’ve lived?

In today's episode I was joined by Dana Adcock, Quality Consultant and former Senior Director of Quality Systems.

I really wanted to speak to Dana because she brings something different to the quality leadership conversation. Yes, she has decades of experience leading global audit and quality systems teams. But what makes her story powerful is how openly she connects her personal journey to the leader she has become.

Dana shares how growing up as an adult child of alcoholics shaped her early career. Avoiding conflict. Playing small. Hiring people who thought like her. Shying away from leadership roles despite being promoted into them.

Over time, through personal hardship, therapy, motherhood, and reflection, she stepped into leadership differently. More intentional. More courageous. More authentic.

We talk about the following:

· How early life patterns show up in leadership behaviour

· Why many capable professionals avoid management roles

· Moving from conflict avoidance to confident, purpose-led leadership

· Building diverse teams instead of hiring people “just like you”

· The mindset shift that happened during her “midlife awakening”

· How adopting her daughter Abby changed how she leads and advocates

· The link between personal resilience and professional courage

· Showing up authentically on LinkedIn and why it felt terrifying

· What “living the fourth quarter intentionally” really means

· Advice for quality professionals who feel pressure to hide parts of themselves

Dana is a thoughtful, courageous and deeply reflective leader who demonstrates that strength in quality leadership isn’t about technical authority alone – it’s about self-awareness, integrity and the willingness to grow.

Thank you Dana for sharing your incredible journey.

Hope everyone enjoys the show!

Timestamps:

(00:00) Introduction

(01:43) Early Challenges in Career Growth

(10:37) Midlife Awakening

(18:06) Embracing Authenticity in Leadership

(28:08) The Importance of Being Seen

In today’s episode, Hemish was joined by Anthony Mire-Sluis, Head of Global Quality at Gilead.

Tony because has lived quality from every angle - UK government and regulatory work, a stint at the FDA, and then senior global leadership roles in major pharma. That perspective is rare, and it shows in how he builds teams and drives change.

Tony’s journey is a brilliant example of how strong quality leadership is less about having all the answers, and more about building trust, listening properly, and creating systems that let people do their best work.

He talks about the following:

• How Tony’s science background (immunology, genetics, and a PhD) shaped the way he leads quality

• What 10 years in government taught him about great vs poor regulatory filings - and why he moved into industry

• The difference between leading a US-centric quality organisation vs a truly global one

• Why building a trusted leadership team is the non-negotiable for running global quality at scale

• How Tony uses his first 90 days: listening, due diligence, and getting under the skin of the culture

• Why he starts transformation from the shop floor - not from the senior leadership layer

• Digital and AI in quality: fix the process first, then digitise (otherwise you just create a clunky digital version)

• How to reduce firefighting and move quality from reactive to proactive - with better workflows and connected systems

• Managing resistance to change and bringing people along early so adoption sticks

• Advice for aspiring quality leaders: networking, knowing yourself, and broadening your experience across quality

Anthony Mire-Sluis is an authentic, people-first quality leader with a rare blend of regulatory depth and big pharma operational experience - and he’s exactly the kind of leader who makes quality a true enabler of the business.

Thank you Tony for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode, Hemish was joined by Ed Armstrong and Jon Voss, two Quality leaders who’ve both worked across early-stage, clinical, and complex biotech environments.

Ed and Jon share what they’re seeing on the ground - from funding pressure and modality shifts, to how regulators are engaging, and where Quality leaders are gaining (or losing) influence.

They talk about the following:

• The current state of pharma and biotech, and whether the market has really bottomed out
• Which modalities and parts of the market feel resilient, and which are still struggling
• How FDA leadership changes are (and aren’t) showing up in day-to-day work
• The shift toward written-only FDA interactions and what that means for sponsor–agency relationships
• Whether regulators are prioritising speed or risk, and how that tension plays out
• Where AI and digital tools are genuinely adding value today, versus where there’s still a lot of noise
• How Quality has evolved from “policing” to partnership over the last 20 years
• Why pragmatic, phase-appropriate Quality systems matter more than perfection
• Burnout in senior Quality leaders and the risk of doing too much with too few people
• What separates Quality leaders who are listened to from those who are merely tolerated
• What the strongest Quality teams will be doing differently by the end of 2026

Ed and Jon bring a huge amount of perspective, humility, and real-world insight to this discussion. This is a conversation for anyone leading Quality through uncertainty and trying to balance patient safety, speed, and sustainability.

Hope everyone enjoys the show!

This week on Let’s Talk Quality, we’re joined by Elisabeth Hutchins, Senior Director of Quality at Upstream Bio, for a conversation focused entirely on one theme:

How quality professionals make the transition from tactical execution to strategic leadership.

In this episode, Elisabeth shares:

• What changes as a company enters Phase 2 and Phase 3
• The moment she realised she needed to stop firefighting and start planning
• How she built the quality team around her to enable strategic thinking
• The soft skills that shape strong future QA leaders
• How to balance urgent deliverables with long-term quality strategy
• Why confidence is essential before others trust you as a strategic partner

Elisabeth brings an honest and practical perspective that will resonate with managers and directors looking to step into bigger leadership roles.

A highly insightful discussion for anyone looking to evolve into a strategic quality leader.

This week, Hemish is joined by Ashley Preston, SVP of Regulatory, Quality and Medical Writing at Blossom Hill Therapeutics, for a conversation about what it really takes to win hearts and minds early in quality leadership.

Ashley took an unconventional path into QA, stepping into his first Quality leadership role after a long career in Regulatory Affairs.

Because of that, he’s had to lead through something far more important than technical depth: communication, trust, and people.

In the episode, Ashley shares:

• Why he moved from Regulatory into Quality leadership
• How to build trust quickly when you’re new to QA
• How leaders can empower technical experts and still influence effectively
• Practical ways to build quality systems and culture in a small biotech
• Why communication, self-awareness and soft skills matter more than ever
• How quality can earn a stronger, more strategic voice at the executive table

Ashley’s perspective is grounded, pragmatic, and incredibly relevant for leaders in emerging and clinical-stage biotech.

#QualityLeadership #Biotech #RegulatoryAffairs #QualityCulture #LetsTalkQuality

From Greenfield to GMP.

In today's episode, Hemish is joined by Kyle Powell, Head of Quality at Ratio Therapeutics.

Kyle is a great example of the next generation of quality leaders who are building from the ground up - combining technical depth with a modern, empathetic approach to leadership.

Kyle’s career is an impressive story of growth, moving from regulatory consulting into radiopharmaceuticals, helping to stand up new facilities, and now leading the full quality build-out for Ratio’s 65,000 sq ft Greenfield site in Salt Lake City. 

He talks about the following:

• How Kyle transitioned from regulatory strategy into quality leadership
• What it takes to scale a quality system in radiopharma from zero to commercial readiness
• Moving from tactical work to strategic thinking as a leader
• Building credibility and influence as a young quality leader
• The importance of empathy and communication in leading teams
• How to justify resources and headcount in a startup environment
• Creating a digital-first, paperless quality function from day one
• Lessons from managing culture and mindset through growth
• The softer skills that separate effective leaders from technical experts
• Advice for early-career professionals aiming to step into leadership roles

Kyle is an ambitious and thoughtful leader - pragmatic, forward-thinking, and people-first.

Thank you, Kyle, for sharing your incredible journey.

Hope everyone enjoys the show!

In today's episode, Hemish was joined by Andrew Jones, former VP, Commercial Quality at Iovance Biotherapeutics.



Andrew is one of the few quality leaders who has actually built a cell therapy site from construction through to BLA submission, FDA inspection and final approval – all while growing and upskilling a team who were doing it for the first time.



Andrew’s career spans 30+ years across biopharma, biotech, cell and gene and commercial launches.

He’s very intentional about principles - listen first, build trust, don’t lie in front of an inspector - and he’s done this in high-pressure, time-sensitive environments where approval is the company’s lifeline.



He talks about the following:


• Moving from validation into site QA at a CDMO and how that set the foundation for future inspection work.

• Lessons from Andrew’s early BLA work at J&J and negotiating specs with R&D and FDA.

• The reality of building a cell therapy facility during the pandemic and getting it inspection ready.

• Why small and mid-sized biotechs underestimate the time vs patience problem in inspection readiness.

• How to break inspection readiness into risk-based subcomponents instead of ‘boiling the ocean’.

• The core inspection principles Andrew teaches his teams (listen first, build trust, never lie).

• How to train a team that has never sat in front of an FDA investigator before.

• The mindset shift from clinical to commercial in cell therapy – and why turnaround time becomes everything.

• Leading at a steady temperature through BLA, inspections and approval.

• Creating a culture where people feel safe to speak up, challenge and improve systems.

Andrew is a calm, values-led quality leader who knows how to get therapies over the line without losing the team in the process.



Thank you Andrew for sharing your incredible journey.



Hope everyone enjoys the show!

In today's episode, Hemish was joined by Theresa Donegan, VP of Quality at Climb Bio.

Theresa has spent the last few years helping biotech startups build quality from the ground up - often as a team of one. 

With 30 years’ experience across every GxP environment, she brings a rare perspective on what it takes to move from large pharma structure to biotech agility, while still protecting compliance and patient safety.

Theresa’s career began in the QC lab before moving through GLP, GCP, and GMP roles in large and small companies, CROs, and now Climb Bio. Her path is a masterclass in adaptability, and in today’s startup environment, her insights couldn’t be more relevant.

She talks about the following:

• How Theresa’s career evolved from QC lab work to VP of Quality leadership

• The mindset shift from big pharma to biotech startups

• What the first 30/60/90 days look like when you’re building quality from scratch

• How to balance pragmatism, speed, and compliance in early-stage biotech

• How to use consultants effectively

• The right time to bring in permanent quality leadership 

• What “good” looks like in an early-stage quality system

• How to align leadership teams and departments when everything is moving fast

• How to spot red and green flags when joining a startup

• The key soft skills quality professionals must build early in their careers

• How to prioritise your first three hires when you finally have budget

Theresa is an incredibly grounded and thoughtful leader, combining technical depth with an empathetic leadership style that every quality professional can learn from.

Thank you Theresa for sharing your incredible journey.

Hope everyone enjoys the show!

From £9,000-a-year QC analyst to global quality leader - Iain Rusling’s story is a masterclass in soft‑skills, grit and making quality a strategic enabler.

In today's episode, Hemish was joined by Iain Rusling, a global Quality & Operations leader and former Chief Quality Officer.

Iain's journey - from QC benches in the UK to leading international, matrixed teams in Europe, captures the mindset, communication, and cross‑functional collaboration required to turn quality into a competitive advantage.

Iain began in QC at small biotechs, built facilities and quality systems, moved through technology transfer and inspections, and later led global/EMEA functions from Munich. 

Along the way he faced setbacks, loss, consulting chapters, and major inflection points - all of which shaped a people‑centered leadership style that keeps him on the shop floor, not behind a desk.

He talks about the following:

• Starting in QC on £9,000 a year and the mindset that accelerated his career
• Building an oligonucleotide facility from scratch and what it taught him about influence without authority
• Moving from site roles to global, matrixed leadership - how to earn trust across borders and cultures
• Inspections and licenses (FDA/MHRA) as leadership pressure tests
• Why quality must be represented in the boardroom - and how to make the case
• Turning ‘quality as a cost’ into ‘quality as continuity of revenue’
• Practical ways quality leaders can humanise their function: walk the floors, speak operations, build relationships
• Interview advice for QA leaders: questions to uncover culture, investment and phase‑appropriate systems
• Clinical → Commercial transitions: where companies get stuck and how advisory/fractional quality leaders help
• AI realism: useful for trends and signals, but it can’t replace human judgment on the shop floor

Iain is a thoughtful, pragmatic leader who combines technical depth with empathy, candour and a relentless focus on relationships.

Thank you Iain for sharing your incredible journey.

Hope everyone enjoys the show!

AI is here - and it’s already changing the way we think about compliance, quality, and productivity in biotech.

In today's episode Hemish was joined by Subbu Viswanathan, Head of Compliance at DashBio.

Subbu because is one of the few quality leaders who has been building and integrating AI into quality systems for over a decade – long before it was mainstream. And he’s now leading quality and compliance at a tech-driven CRO, where speed and automation are core to the model.

Subbu’s journey spans shop floor experience, software development, cloud QMS implementation, startup failures, AI audit tools, and now redefining what a modern bioanalytical CRO can be.

He talks about the following:

• What quality looks like when you build a company from scratch with AI and automation at the core.

• How to move fast without breaking compliance.

• What GLP and GCP readiness really involves in a fast-paced environment.

• How to use LLMs and automation to handle audit questionnaires and generate CAPAs.

• Why most GenAI pilots are failing in biotech.

• How to think clearly about the noise vs. signal when it comes to AI tools.

• Why quality leaders need to be AI-literate to stay relevant.

• The slow death of traditional entry-level QA jobs – and what might replace them.

• Why AI won’t take your job – but someone using AI better than you will.

• What a good quality mindset looks like in the age of digital transformation

Subbu is a brilliant thinker who brings clarity, experience, and grounded insight to an often confusing topic.

Thank you Subbu for sharing your incredible journey.

Hope everyone enjoys the show!

In this episode, Hemish was joined by Karin von Hodenberg, VP of Quality at Monte Rosa Therapeutics.

Karin has repeatedly built quality systems from the ground up across med device and biotech, and she translates that experience into practical, phase-appropriate guidance for early teams.

Karin’s journey is anything but typical: a business background, supply chain and Lean Six Sigma Black Belt training led her into quality at GE Healthcare and Philips, before moving into biotech with bluebird bio during rapid growth. She’s since led in several startups and now at Monte Rosa, where she’s implemented validated systems early and embedded a genuine culture of quality across GxP.

She talks about the following:

• Why a non-traditional path (business → supply chain → Six Sigma) can be a superpower in Quality.
• From paper to validated eQMS: how bluebird bio migrated training & documents and why they verified 100% of records.
• Trigger points for moving beyond paper: signs you’re outgrowing a doc control room and how to stand up DMS/LMS/LIMS early.
• Phase-appropriate, risk-based thinking: using data, science and regulations - without becoming a blocker.
• Making quality ‘cool’: education, storytelling, and visible sponsorship from ELT.
• Leading without fear: replacing “inspection readiness day” with “inspection readiness every day.”
• Critical thinking over checkbox compliance: hiring, interview questions, and building the muscle across teams.
• Working with functional heads: cadence of 1:1s, being a partner (not a gate), and influencing through solutions.
• Roadmaps that breathe: Karin’s 3‑year plan, quarterly outcomes, and how transparency sustains engagement in uncertainty.
• AI pragmatism in quality: where note-taking and drafting help now - and where human judgment still rules.

Karin is a thoughtful, pragmatic Quality leader who balances compliance with business value - bringing people with her as she builds systems that last.

Thank you Karin for sharing your incredible journey.

Hope everyone enjoys the show!

Creating order from chaos: how a VP of Quality builds trust, leads through constraints, and keeps teams focused on patients.

In today's episode Hemish was joined by Sep Naraghi, Vice President of Quality & Regulatory Affairs at Cellularity Inc.

Sep has led quality in both Big Pharma and startups and has a practical, people-first approach to building trust, making trade-offs, and delivering under resource constraints.

Sep’s journey is anything but linear: from QC in generics to supplier quality at Boehringer Ingelheim, to leading quality and regulatory in a startup. His leadership philosophy is anchored in two values—trust and order—and he’s candid about how feedback early in his career reshaped how he manages one-to-ones, builds transparency, and partners across the business.

We talk about the following:

• Early path: QC in generics to supplier quality at Boehringer Ingelheim and an accelerated step into leadership.
• The two values that guide him—trust and order—and how childhood experiences shaped them.
• What changed in the industry: from “quality as police” to quality embedded early and driving value.
• Practical ways he learned softer skills: asking more questions, reading the room, and focusing on people in 1:1s.
• Big Pharma vs startup: resource constraints, creative problem-solving, and prioritising the ‘must-haves’.
• Keeping culture strong under pressure: transparency, bi-weekly team forums, and cross-functional partnership.
• Managing up and across: using a ‘ladder of inference,’ lunch-and-learns, and making the logic visible.
• Hiring and fit for startups: flexibility, curiosity, blunt-but-respectful dialogue, and support from your boss.
• Creating order from chaos: bringing structure to reach IND/BLA milestones without losing speed.
• Advice for aspiring leaders: lean into discomfort; empathy over ego; and build trust before you need it.

Sep Naraghi is a thoughtful, values-led leader who turns ambiguity into execution, champions transparency, and builds teams that do the right thing for patients and the business.

Thank you Sep for sharing your incredible journey.

Hope everyone enjoys the show!

From rock guitarist to VP of Corporate Quality, Tony shows how principles, clear choices, and modern tools like AI can level-up how quality leaders think and operate.

In today's episode, Hemish was joined by Tony Jones, Vice President, Corporate Quality at Syneos Health.

Tony’s path is anything but typical: NHS clinical biochemistry, clinical pharmacokinetics at Beecham/GSK, a move to France, and then landing, almost by accident, in QA leadership in New Jersey. He went deep on GLP and data principles, published prize-winning work, and has since focused on education, strategy, and the creative application of regulation to help teams do their best work.

He talks about the following:

• The unconventional route from aspiring guitarist to Director of QA and beyond.
• What clinical labs taught him about data and why that matters in pharma/biotech quality.
• GLP as a canvas: distilling regulation into simple, durable principles.
• Data integrity beyond acronyms: accuracy, completeness, consistency and study reconstruction.
• Why strategy is a set of choices (Roger Martin) and leaving room for emergence (Mintzberg).
• Decision-making lenses leaders can actually use: broaden options, avoid false binaries, and think before acting.
• Critical thinking by design: two questions - “What’s going on?” and “What should I do about it?”.
• AI in the quality toolkit: daily use cases, custom agents, and why bottom‑up experimentation matters.
• Training and culture: shifting from static courses to on-demand, problem-first learning.
• Career advice: learn continuously, evidence change, take morning walks, make space for reflection.

Tony is a thoughtful, principles‑driven quality leader who blends scientific depth with practical strategy and a genuine passion for learning and teaching.

Thank you Tony for sharing your incredible journey.

Hope everyone enjoys the show!

In this week's episode, Hemish was joined by Scott Pherson, Senior Director of Quality Assurance at AS2 Bio.

Scott has made the transition from big pharma to startup biotech three times. And now, he’s building quality from scratch at a company that hasn’t even dosed a patient yet.

Scott has nearly 20 years’ experience across QC, operations, and quality leadership, having worked at Biogen, Shire, AvroBio and more. Now, as the first quality hire at AS2 Bio, he’s building systems, shaping culture, qualifying vendors, and laying the groundwork for clinical success.

He talks about the following: 

🎙️ Moving from large pharma to lean biotech 

🎙️ How to stand out in startup interviews 

🎙️ Why AS2Bio hired quality *before* going to clinic 

🎙️ How to prioritise when you’re the first quality hire 

🎙️ What founders get wrong about consultants 

🎙️ Cultural priorities when embedding quality early 

🎙️ Building brand value to attract talent in Boston 

🎙️ The mindset needed to thrive in ambiguity 

🎙️ His player-coach leadership style 

🎙️ His advice to aspiring quality leaders

Scott is a thoughtful, experienced and humble leader - someone who blends strategy, scientific rigor, and people-first leadership to help biotech companies move fast without cutting corners.

Thank you Scott for sharing your incredible journey.

Hope everyone enjoys the show!

In today's episode, we are joined by Stephanie Martin, Director of QA and Product Quality Lead at Adaptimmune.

Stephanie's journey into quality leadership is anything but traditional. She started out as a nuclear engineer at a shipyard before pivoting into biotech and building a career in quality.

What stands out is how she has faced bias around her age and appearance head-on, and still accelerated into leadership roles by focusing on EQ, credibility, and consistent performance.

Stephanie's story is a brilliant case study in how you can lead without waiting to be told you're ready.

We talk about the following:

🎙️Starting her career in a shipyard as a nuclear engineer.

🎙️Developing emotional intelligence in an industrial setting.

🎙️Transitioning into biotech and discovering her passion for quality.

🎙️Why a Director saw leadership potential in her before she did.

🎙️How she learned to influence without direct authority.

🎙️Overcoming bias around age, appearance, and experience.

🎙️Building credibility and scaling her impact at TCR² and Adaptimmune.

🎙️The mindset shift from tactical to strategic decision-making.

🎙️Her approach to hiring and coaching future quality leaders.

🎙️The advice she’d give to other young leaders looking to make their mark.

Stephanie is a thoughtful, driven, and emotionally intelligent leader who’s helping shape the future of quality in cell and gene therapy.

Thank you Stephanie for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode, I was joined by Megan Callan, Vice President of Quality at Abeona Therapeutics.

I really wanted to speak to Megan because her last few years at Abeona have been a masterclass in building a quality organisation that can handle the demands of commercial manufacturing - all while driving a digital transformation and keeping a patient-first mindset.

Megan has a unique career journey, moving across different industries and company sizes, and in this conversation, she opens up about how she’s navigated the shift from tactical to strategic leadership, what it takes to scale a quality team rapidly, and how AI is already influencing the role of QA.

We talk about the following:

🎙️ Megan’s early career moves and how she found her way into quality

🎙️ Leading Abeona’s scale-up from early clinical to commercial readiness

🎙️ Growing a QA team from 5 to 60+ people in a short timeframe

🎙️ The shift in mindset from tactical execution to strategic leadership

🎙️ Lessons learned from a major digital transformation project

🎙️ How to align quality with business objectives and patient needs

🎙️ Building resilience and navigating change at pace

🎙️ The role AI and IT now play in quality operations

🎙️ Advice for aspiring quality leaders who want to step into senior roles

Megan is a thoughtful and forward-thinking quality leader whose approach blends business acumen, strategic foresight, and a deep commitment to patient outcomes.

Thank you, Megan, for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode I was joined by Nolan Polson, Vice President of Quality Assurance and Product Quality at Iovance Biotherapeutics.

I really wanted to speak to Nolan because he’s one of the few leaders who’s built quality teams at every stage – from biologics at Amgen to radiopharma at Janssen, to launching two first-in-class cell therapies at Juno/Celgene/BMS.

Nolan’s career path is a great example of what it looks like to carry foundational quality principles into fast-paced, high-growth settings. He talks about his early scientific passion, how he transitioned from R&D to Quality Ops, and the leadership mindset required to scale from clinical to commercial.

We talk about the following:

• How Nolan's scientific roots in chemistry shaped his quality mindset
• Transitioning from R&D into Quality Ops and building speed with structure
• What Big Pharma taught him about good science, mature systems, and agency collaboration
• Scaling product quality teams from 2 to 45 during two cell therapy launches
• Building empowered leadership teams and the traits he looks for when hiring
• How AI can help quality teams move toward review-by-exception and proactive oversight
• The difference between biologics and cell therapy mindsets in a commercial setting
• Creating a culture of continuous learning and succession planning
• Lessons from moving across Amgen, J&J, GSK, BMS, and Iovance
• Why autologous cell therapy still holds massive curative potential

Nolan is a thoughtful, experienced quality leader who blends deep scientific expertise with a calm, strategic leadership approach.

Thank you Nolan for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode I was joined by Ashley Argiras, VP of Quality at Recursion.

I really wanted to speak to Ashley because she’s helping redefine what quality leadership looks like in a tech-enabled, platform biotech - and she’s doing it by shifting how people think, not just how they work.

Ashley’s journey into science started in high school - not in a lab, but making ice cream during chemistry class. That moment sparked a lifelong curiosity that took her to Indiana University, and eventually into clinical research. She began her career as a CRA at Eli Lilly, where she visited trial sites and became the first line of quality, working hands-on with investigators to ensure patient safety and protocol integrity.

That experience gave her a real-world understanding of what quality means at the ground level, and it’s shaped the way she leads today: rooted in purpose, driven by questions, and always looking for better ways to serve patients.

We talk about the following:

🎙️ How quality supports speed in a platform biotech

🎙️ Ashley’s early career in clinical trials and where it all began

🎙️ Teaching teams to ask better questions, not follow checklists

🎙️ What “inspection ready” really means in a modern organisation

🎙️ Why judgment and empowerment are better than policy and policing

🎙️ How Ashley thinks about org structure during scale-up

🎙️ Leading with listening (and learning to talk less as a VP)

🎙️ Avoiding the bottleneck trap as a quality leader

🎙️ Building a safe space for decisions - even if they’re wrong

🎙️ Lessons in growing from tactical QA to strategic leadership

Ashley is a sharp, thoughtful leader proving that real quality leadership starts with having the right mindset.

Thank you, Ashley, for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode I was joined by Maja Pedersen, Chief Technology Officer at Fujifilm Diosynth Biotechnologies.

I really wanted to speak to Maja because she leads quality and IT across six global sites, and has a brilliant perspective on how quality leadership is evolving - especially when it comes to people, systems and technology.

She has a calm, clear way of thinking, and we covered everything from shifting your mindset as a leader, to integrating AI in a global quality function, to maintaining personal resilience and clarity.

We talk about the following:

🎙️ Making the leap from tactical to strategic thinking

🎙️ Leading teams across multiple countries, time zones and cultures

🎙️ Building trust in new teams and showing up authentically

🎙️ Balancing the people side of quality with system thinking

🎙️ How to think and lead when you're not the technical expert

🎙️ Staying grounded and maintaining well-being while leading at scale

🎙️ Where quality and IT need to work hand in hand

🎙️ Why quality leaders must develop digital and data fluency

🎙️ How AI will reshape the future of quality in biotech

🎙️ Advice for future leaders stepping into global roles

Maja is a thoughtful, strategic leader who balances big-picture thinking with deep care for people and culture.

You can watch on LinkedIn Live at 8am EST today or listen via Apple or Spotify.

Thank you Maja for sharing your incredible journey.

Hope everyone enjoys the show!

From engineering student to SVP of Quality - Carolina shares how curiosity, resilience, and mentorship shaped her journey.

In today’s episode I was joined by Carolina Valoyes, Senior Vice President of Quality and Compliance at BioNova Scientific.

I really wanted to speak to Carolina because her story is one of bold decisions, genuine self-awareness, and a leadership style grounded in service, not ego.

She started out as an engineer in Colombia, came to the US without speaking a word of English, and moved her way into biotech leadership by staying curious, staying humble, and always aiming to contribute. Her reflections on mentorship, emotional resilience, and coaching-based leadership were powerful.

🎙️ We talk about the following:

• How she went from Colombia to the US without knowing English and starting her career in Biotech at Bayer 
• Her first role supervising a team 15 years her senior
• What an early inspection mistake taught her about resilience
• Her transition from manufacturing into quality
• The guiding principles that drive her career decisions
• Whether curiosity can be taught - and how to coach it
• The importance of painting a positive vision, not using fear
• Advice for navigating “politics” at VP level
• What she looks for when hiring leaders 
• Her advice to aspiring quality leaders

Carolina is an inspiring leader who brings humility, sharp thinking, and deep care for people into every part of her work.

Thank you, Carolina, for sharing your incredible journey.

Hope everyone enjoys the show!

In this episode of Let’s Talk Quality, Hemish speaks with Jose Caraballo, a biotech leader with over 30 years of experience in process engineering, manufacturing science, and quality leadership.

Jose started his career in process engineering, optimizing yields and scaling up production. 

Over time, he made a deliberate shift into quality leadership, recognizing that understanding the external side of the business - suppliers, regulators, and customers, was just as important as technical expertise.

Now, as a VP of Quality at Kite Pharma, a leader in cell therapy manufacturing, Jose is deeply involved in shaping the future of quality in biotech and remains passionate about driving innovation and leadership in the biotech space.

In this conversation we cover:

✅ The shift from compliance-focused quality to strategic quality leadership

✅ Why quality is a company-wide responsibility, not just a QA function

✅ How moving from technical roles to quality leadership can accelerate career growth

✅ The importance of curiosity and adaptability in biotech

✅ How CGT is changing expectations for speed, risk management, and patient impact

✅ The role of automation and AI in quality systems

✅ Lessons from moving into senior leadership and managing teams effectively

✅ What biotech companies need to focus on to embed quality culture at every level

Jose’s career journey is a great example of how technical expertise, business strategy, and leadership all come together to drive impact in biotech.

This week on Let’s Talk Quality, we sat down with Andrea Karpinecz, VP of Quality Control at Iovance Biotherapeutics, to discuss what it takes to build a successful QC career, scale teams for commercialization, and thrive in a high-pressure environment.

Andrea has been in cell therapy for 16+ years, playing a pivotal role in bringing multiple therapies to market - including some of the first commercially approved CAR-T and TIL therapies. She’s seen firsthand what it takes to move from the bench to executive leadership and shares key insights for QC professionals who want to grow their careers but aren’t sure where to start.

🚀 In this episode, we cover:

✔ How to transition from a technical QC role to leadership

✔ Lessons from leading QC for two commercialized cell therapies

✔ The biggest challenges in preparing for commercialization and how to solve them

✔ Why hiring for mindset is just as critical as technical expertise in QC

✔ How to build resilience as a leader in a high-pressure, fast-moving environment

✔ The future of cell therapy and what it means for QC careers

For QC professionals wondering what’s next in their careers, Andrea breaks down why moving into leadership doesn’t mean leaving QC. There’s a clear path forward—whether you want to become a VP, Director, SME, or eventually step into executive roles.

🔹 This episode is a must-watch for QC leaders preparing for the commercialization of an ATMP.

🚀 The first-ever returning guest on the podcast!

In this episode, Hemish sat down with Brian Nunnally, Enterprise Quality Control Head at CSL, to dive deep into one of the most important topics in career growth - mentorship.

Brian’s career is a perfect example of how mentorship, strategic career moves, and leadership development can accelerate your path to the top. He shares his journey from QC scientist to leading an entire global Quality Control organization, and why having the right mentors at the right time made all the difference.

💡 Key topics we cover:

• 🔬 How Brian navigated multiple lateral career moves to break through to VP level
• 📈 Why mentorship is crucial at every stage of your career (even for senior leaders!)
• 🎯 How to find the right mentor and what questions to ask
• 💡 Why focusing on strengths, rather than weaknesses, can drive faster career growth
• 💬 How leaders can stay positive (without being fake)
• 👥 The power of paying it forward - why senior leaders should invest in mentoring the next generation.

📺 Watch the full episode today at 12pm EST on LinkedIn Live

🎧 Listen on Apple & Spotify

If you're a Quality professional who might be feeling stagnant in your career, break through plateaus, improve your mindset, or find the right mentor, this episode is for you. 

🎙️Would you move to a new country with no network, no guarantees - just a dream and two suitcases?

That’s exactly what Katarina Bartle did.

She left Slovakia, where she had built a strong academic foundation, moved to Germany for her PhD, and then took a huge risk, relocating to the U.S. for what was meant to be a short postdoc.

27 years later, she’s still here - now a biotech quality leader who has shaped global teams and helped redefine how companies approach quality.

In today’s episode of Let’s Talk Quality, Katarina shares:

✅ The challenges of moving to a new country and building a career from scratch

✅ How she transitioned from scientist to compliance and quality leader

✅ The importance of having a strong voice in leadership discussions

✅ Why quality leaders need to think like business leaders, not just auditors

✅ Her biggest leadership lessons and career advice for aspiring VPs

This one is packed with career insights, resilience, and real leadership lessons—don’t miss it.

In today’s episode, I was joined by Biana Torres, Senior Director of Quality Assurance at Encoded Therapeutics.

I really wanted to speak to Biana because she has built a strong leadership career in quality, moving through both big pharma and small biotech. She’s now leading in the dynamic world of cell and gene therapy, where quality and adaptability are critical.

Biana started out aiming to be a doctor, pivoted into biotech by accident, and has since built a career leading quality teams through acquisitions, evolving regulations, and high-impact projects that put patients first.

We talk about the following:

🎙️ Her unexpected entry into quality through a temp job at Baxter

🎙️ The transition from big pharma to small biotech and what she learned from both

🎙️ Why cell & gene therapy is different from traditional small molecule and biologics

🎙️ How quality leadership has evolved from being "the police" to a business partner

🎙️ The impact of working at Kite during a pivotal time for the industry

🎙️ How she overcame the "no CGT experience, no interview" hiring barrier

🎙️ The mindset shift needed to work in advanced therapies

🎙️ The importance of coaching & mentorship in leadership development

🎙️ Why future quality leaders need to think outside the box

Biana is a passionate leader who thrives in fast-moving biotech environments. She’s driven by curiosity, continuous learning, and a commitment to mentoring the next generation of quality leaders.

Thank you, Biana, for sharing your incredible journey.

Hope everyone enjoys the show!

In today’s episode, I was joined by Shane Ernst, Vice President of Quality at Empower Pharmacy.

I really wanted to speak to Shane because he has built an incredible career in quality leadership despite being an introvert - a trait many in the industry can relate to. His journey from analytical chemist to VP is full of valuable insights on leadership, career progression, and navigating high-stakes regulatory challenges.

We talk about the following:

🔹 How he accidentally fell into quality after starting in analytical chemistry

🔹 The early career moment that forced him to step up despite his introverted nature

🔹 Why quality leaders need to develop cross-functional business knowledge

🔹 His biggest leadership challenge - building confidence as an introvert

🔹 How he learned to manage his energy as a leader while staying authentic

🔹 What it was like turning around a 1,300+ complaint backlog at a major pharma site

🔹 Why trust with regulators is essential and how to build it

🔹 The shift from tactical to strategic thinking when moving from Director to VP

🔹 How he develops and mentors future leaders in quality

🔹 His advice for aspiring VPs - getting out of your comfort zone is key

Shane is a fantastic example of how leadership isn’t about personality type - it’s about mindset, adaptability, and growth. His story proves that introverts can thrive in senior leadership roles and have a huge impact on their teams and companies.

Thank you, Shane, for sharing your incredible journey.

Hope everyone enjoys the show! 🚀 

In this episode of Let’s Talk Quality, Hemish sat down with Rob Dallimore, Head of Quality at Wugen, to discuss his inspiring 25+ year journey in quality assurance and leadership. Rob’s experience spans small molecules, biologics, and cell therapy, giving him unique insights into what it takes to succeed across different modalities.

Rob shared invaluable lessons from his career, including the mindset required to pivot into new areas of expertise, how to build resilient teams, and his experience leading quality systems for commercialization at both start-ups and Big Pharma.

Key highlights include:

🎤 Rob’s transition from the UK to the US and stepping into leadership roles.

🎤 The challenges of job hunting in a highly competitive biotech industry.

🎤 Navigating the shift from small molecules to biologics and cell therapy.

🎤 How to hire and train QA teams without specific modality experience.

🎤 The importance of leading with empathy, resilience, and adaptability.

🎤 Building compliant, efficient quality systems for commercial readiness.

🎤 Lessons learned from late-stage clinical trial failures and bouncing back stronger.

🎤 Wugen’s mission to license the first allogeneic CAR-T therapy in the US.

Rob’s career demonstrates the power of stepping outside your comfort zone and taking on challenges to drive meaningful impact in the life sciences industry. 

Thank you, Rob, for such an insightful conversation. We’re looking forward to seeing Wugen’s exciting journey unfold.

In today's episode, I'm joined by Jon Voss, one of the all-time quality greats!

I've been working with Jon over the past 18 months. I'd describe him as a true gent - very humble, incredibly funny with a dry sense of humour, and someone who is so passionate about this industry.

Unsurprisingly he has developed some of the leaders I've interviewed on this show!

What shines through in this episode is the balance between pragmatism and patient safety.

We talk about the following: 

• The evolution of quality from compliance-driven to patient-first approaches
• Why and how moving around different careers benefited Jon's career.
• Lessons learned from leading quality teams through commercialization milestones.
• Phase appropriate quality and how to actually implement systems accordingly.
• Keeping the end goal in mind whilst maintaining patient safety.
• Utilising Technology and AI to speed up drug development
• How to transition into commercial quality.
• Why learning how to speak in public will improve your career opportunities.

 Jon is so passionate about helping and inspiring the next generation of leaders. His stories and advice offer invaluable insights for anyone working in or aspiring to quality leadership roles.

Thank you, Jon, for sharing your incredible journey, wisdom and lessons you've learnt.

Whatever level you are in your career, there is something to be learned from in this episode.

Hope everyone enjoys the show!

On this week's episode of Let's Talk Quality: The Podcast🎙️Hemish Ilangaratne is joined by Hanh Nguyen, Site Head of Quality at Minaris Regenerative Medicine, a global CDMO specializing in cell and gene therapies.

Hanh’s career started in document control at Amgen, spending over a decade in Big Pharma, before taking a leap into smaller, fast-paced organizations. That move - stepping out of her comfort zone, was a pivotal moment that accelerated her growth and confidence as a leader.

Hanh is a brilliant example of someone who’s balancing rapid career progression with deep self-awareness. In this episode, she opens up about:

✅ Overcoming imposter syndrome and trusting your experience.

✅ How to adapt your leadership style to motivate and engage a new generation of talent.

✅ The importance of prioritizing mental health - both for yourself and your team.

✅ Creating strong relationships between sponsors and CDMOs to drive success.

If you’re a quality leader (or aspiring to be one), this episode is packed with practical tips and insights on building high-performing, engaged teams while staying true to yourself.

Hope you enjoy the show!