We are back for Season Two of Lets Talk Quality!

This week, I had the pleasure of speaking with Irving Ford, VP of Quality at Adaptimmune Therapeutics.

Irving has been through the commercialisation of four cell therapy products, most recently leading Adaptimmune through the BLA and FDA approval of their engineered T cell for solid tumour, Tecelra.

Irving talks about his journey from starting out his career as a Microbiologist before making his transition into the pharmaceutical industry. He started in a generics company which exposed him to a variety of product types. He worked his way up into leadership positions, across multiple different aspects of quality, to get to where he is now.

Takeaways

• The benefit of working in multiple aspects of quality in your early career
• Developing trust and building leadership capabilities
• Developing different generations of people
• Putting yourself out of your comfort zone in your career
• Key ingredients for moving from clinical to commercial operations in cell therapy
• Unlearning everything you've learnt when working in cell therapy
• Training for mindset and continuous development
• Managing stress, workload and your emotions
• Irving's values, views on legacy, inspiration, and advice for future leaders!

Chapters

• 00:00 Introduction and Overview of Irving Ford
• 03:00 Transitioning from Clinical to Commercial Operations
• 11:33 Building Strong Relationships and Creating a Positive Work Culture
• 19:24 Challenges and Real-Time Decision Making in Cell Therapy
• 25:30 Personal Values and Leaving a Legacy
• 32:18 Advice for Future Quality Leaders

Huge thank you to Irving for giving us his time!

Joe Franchetti, President of the Society of Quality Assurance (SQA), shares his vision for the SQA and the wider quality assurance industry, emphasizing the importance of collaboration and expanding relationships with international quality colleagues and regulators. Joe highlights the need to attract and educate younger professionals about the field of quality assurance. He discusses the role of technology, including AI and blockchain, the challenges and opportunities they present, as well as offering advice for future quality assurance professionals.

• 01:25 - Election as President of SQA
• 05:09 - Vision for SQA and the Quality Assurance Industry
• 07:27 - Promoting Quality Assurance as a Career
• 10:09 - Challenges in Attracting Young Professionals to Quality Assurance
• 13:39 - The Role of Technology in Quality Assurance
• 27:26 - Advice for Future Quality Assurance Professionals
• 29:04 - Joe's Inspiration and Motivation
• 31:02 - Information about SQA and its Benefits

It was a privilege to be joined by Joe and hear him discuss his vision for the SQA, the wider industry, the role that technology will play, and what benefits the SQA can offer to future and existing members.

Thanks for listening, I hope you enjoy the show!

This week I spoke with Jacob Patterson, VP quality for a clinical stage biotech in Rhode Island.

Jacob, by his own admission, has had to continuously adapt, learn and be flexible in his approach to quality leadership. We had a great conversation about what skills the quality industry will demand in the next 10-20 years. We spoke about what Jacob thinks quality professionals should be doing now, from both a technical skills and a leadership perspective to help grow their career, develop succession, and become a great quality assurance leader in the future. We covered the below in detail:

• Working in a smaller biotech compared to larger organizations
• What makes a high performing quality function today?
• How times have changed and why quality isn't known as the police any more
• How speed, agility and data analysis are the skills quality professionals need to be learning now
• Data integrity and analysis, and it's significance
• How the industry can develop more quality leaders
• Managing people and how to deal with difficult employees
• Defining the ROI of quality and getting quality a better seat at the table
• What to look for in your people when building a team

Thank you to Jacob for giving us his insights into the world of quality assurance and it's future. Jacob is honest about his assessment of the current landscape of quality assurance and what he believes, the skills that QA professionals should be working on now, to build a successful career for the future.

Hope you enjoy the show!

This week, we spoke with Brian Nunnally, and discussed some of the challenges that Brian faced throughout his journey to where he is now, Global Head of QC at CSL.

Brian is hugely passionate and is driven by being a part of and leading the best quality control function in the world.

What I liked about this conversation was Brian's honest assessment of his struggles and frustrations that many people will be going through right now. We spoke about why lateral moves and working in different functions might sometimes not be a bad thing for your longer term career prospects. We also delved into what a great QC team looks like - the metrics that Brian holds his leaders accountable to and the key pillars to building a global QC function.

We cover the below in detail:

• How having different experiences in QC, regulatory, technical has shaped Brian's career
• How a lateral move can benefit you in the long term
• The importance of multiple mentors in the early and middle phases of your career
• How to build resilience in your career and advice on identifying your 'North-Star'
• The three key things which make a world-class QC team
• The metrics that Brian and his team monitor
• Brian's leadership style and how he develops his people
• What makes a great QC leader

Brian was a pleasure to speak with. His journey to now being part of an organisation that is developing vaccines that saves lives is inspiring. This is a must listen for anyone who is leading a QC team or an aspiring QC leader. In addition, for anyone who is feeling frustrated with their career progression, Brian provides some great advice for getting through the frustrating times, really understanding what you want to achieve and where you want to go.

Hope you enjoy the show!

This week I was joined by Peggy Owens, Head of Quality at Kincell Bio, a CDMO operating in early phase cell therapy.

Peggy has an extensive background in cell therapy, having worked on both the CDMO and sponsor side. We had a great discussion about the challenges of building and leading a quality function in an area of medicine which is constantly evolving. We discussed the following:

• The challenges of overseeing quality at a CDMO in the CGT space
• How to develop a team that can operate in uncertain environments
• The importance of quality working 'on the floor' alongside manufacturing
• How to develop processes and procedures to upskill your team
• How to go about getting 'the right people in the room'
• Examples where things have gone wrong and how Peggy handled this
• The differences between working in a CDMO v sponsor side
• Advice for collaboration between CDMO's and the sponsor company

Peggy's attitude towards quality, the industry, and the patient is inspiring. One of the goals of this is show is to inspire future quality and biotech leaders. Peggy's purpose and motivation shines through in this episode, and she provides an excellent insight into how to develop and upskill quality professionals to help them operate in the grey area of cell therapy, particularly in the fast-paced CDMO world.

Thank you to Peggy for coming on the show and providing such great insights.

I hope you enjoy the show!

On this weeks show, I speak with John McKay, a well respected, well loved and highly seasoned quality assurance leader in pharma and biotech across clinical development and commercial manufacturing.

John breaks down four key pillars that he believes are critical for achieving quality assurance excellence and developing world-class quality functions. We discuss the following:

• What it takes to be a great quality assurance leader
• John's experience of being trained by Dr W. Edwards Deming
• The importance of senior leadership teams commitment to quality
• How John uses his sporting experience to help coach his team members
• The importance of team-work and collaboration across the business
• How to excel in global know-how through knowledge management
• John's advice for future quality assurance leaders

Thank you to John for giving us some key insights into some of the key factors that contribute to becoming a world-class quality leader. It's always a pleasure to speak with John. His positivity and energy is infectious and you can see how he's forged such a successful career in quality. He is a great mentor for anyone looking to develop their leadership career.

I hope you enjoy the show!

Welcome to episode 6 of Let's Talk Quality.

I was joined by Greg Whitehead. Greg is Head of Quality at Editas Medicine and has been working in biotech for 30 years, with a particular focus on cell and gene therapy.

Greg has a vision to leave the quality assurance industry in a better place than when he started in the industry. We spoke about why this is important to him and what he is doing to help bring this vision to life. We spoke about the following:

• How not many people set out to have a career in quality assurance, and why this is
• a benefit to the industry.
• As Greg grew in his career, why he began thinking about what he's leaving behind in the QA industry.
• How to relationships with regulatory bodies and health authorities have evolved over the years.
• Greg's advice for inexperienced QA professional in how to work well with the FDA.
• What makes a truly talented quality assurance leader in biotech.
• Embedding quality as a culture and mindset in the industry.
• Finding the balance when building quality functions.
• The legacy Greg wants to leave behind him.

Greg has a huge passion for the quality assurance industry and developing leaders that can help move the industry forward. He has achieved a lot in his career so far, and will continue to add value to the wider industry. I'm looking forward to seeing Greg and the team at Editas develop their gene therapies as they move closer to bringing them to commercial use.

Greg was an inspiration to speak with, and I'd urge any QA professional looking to develop their leadership career to listen and reach out to Greg!

I hope you enjoy the show!

There are 6 female CEO's of biotech companies with a market cap of over $5bn.

In this episode, I was lucky to speak with Christy, who is an incredible advocate for females in quality and the wider biotech industry. Christy has an incredible passion for helping other females leaders overcome some of the struggles that she has faced in her career. Christy chairs a women in quality group for ASQ where men and woman come together to break down the barriers and challenges for woman in the workplace and what both men and woman can do to help overcome these challenges.

• Why Christy is such a strong advocate for females in quality assurance
• Some of the key obstacles female leaders typically face in biotech
• The role that mentors can play in personal and career development
• Importance of finding a great mentor who is in line with your values
• Specific aspects females can struggle with in negotiating
• Building credibility and being seen as a valued business partner
• The benefit of really getting to know people in your company and network
• The 'Circle Philosophy' - what this is and how it can influence your life
• How being self-aware in minimising unconscious bias in the work-place
• How to find a good work-life integration
• The importance of aligning your company with the culture that you want to create
• The advice Christy would give to her younger self
• Christy's vision for woman in quality assurance

This is a conversation that should consistently be happening. For the industry to continue to develop and grow, we need more female leaders, and we need more people like Christy helping those who may be facing the same challenges she has faced in her career.

Christy gives some really practical advice to females at any level who are looking to build their personal and career development. Whether you’re a male or female, this episode will give anyone in the work-place some great insights into the challenges females face, and what everyone can be doing to on how to help create a better culture, improve employee retention and progress the industry forward.

I hope you enjoy the show!

What exactly is 'phase-appropriate' quality?

In episode 4 of Let's Talk Quality, I was joined by Amnon Eylath to discuss the origins of the well known term, 'phase-appropriate' quality. Amnon and I discuss the following:

• What exactly is 'phase-appropriate' quality?
• The history of GxP and how the term originated
• How the FDA guidance has evolved, and how it started
• Amon's role in liaising with the FDA to develop a 'graded approach' to quality
• How this approach evolved into the term 'phase-appropriate'
• What factors to consider when implementing quality that is 'phase-appropriate'
• Real-life examples where this impacted the commercialisation of therapies
• Managing upwards with C-suite to promote quality within an organization
• The importance of understanding the science and technology
• What inspires Amnon to progress and contribute to society

This is a fascinating discussion about such a widely used phrase in quality assurance and the wider pharma and biotech industry.

Amnon's knowledge on this subject matter dates back to before the term was coined and it's fascinating to speak to someone who played a significant role in identifying the importance of implementing quality at the right time and to the right extent.

Hope you enjoy the show!

Welcome to Episode 3 of Season 1, of Let's Talk Quality: The Podcast.

Hemish was joined by Ann Farnsworth. Ann is the VP of Quality Assurance for C4 Therapeutics, a clinical phase biotechnology organisation, headquartered in Massachusetts.

Ann explains why understanding the history of quality assurance is a key part of her leadership philosophy and details the practical measures she takes when onboarding new team members. We cover the following in detail:

• Ann's customizable onboarding process for new QA team members
• Why understanding the history of quality assurance improves employee engagement
• How she makes it engaging and fun for new team members
• The timelines of regulations put in place and the tragedies that have occurred
• How she customizes her approach to different personalities or seniorities
• The importance of bringing in quality early in a company journey
• Measuring return on investment of quality assurance
• How to define the ROI to upper management
• Ann's advice to future quality leaders

Anne offers some great practical guidance for any level of quality professional, particularly when it comes to having a customizable process to onboard new colleagues through making quality relatable.

Hope you enjoy the show!

Welcome to Episode 2 of Let's Talk Quality!

Today's guest is Edward Armstrong.

Ed is the VP of Quality at Mustang Bio.

What stood out about the conversation with Ed was his passion for continuous learning in quality and why all QA professionals should always be looking to adapt, overcome and improvise in quality and compliance.

• What makes a great quality assurance leader in today's world
• How has quality evolved in the past decade
• The significance of what the team at Mustang Bio are doing
• Autologous cell therapy and Car-T and the impact it has on patients
• How cell therapy has evolved over the past decade
• How the regulatory agencies and manufacturers are collaborating better
• Challenges faced in autologous cell therapy
• Scaling up manufacturing of autologous cell therapy
• Phase appropriate quality in clinical development
• Preparing for quality management maturity regulations
• Ed's leadership style and the values and principles he holds
• Which attributes Ed looks for in future quality leaders
• Why quality is not the office of product prevention!
• Why you have to be a good learner for a career in quality assurance
• Ed's life outside of his work!

I really enjoyed the conversation with Ed. He comes across as an exceptional leader and clearly leads from the front, with purpose, and 'shoulder to shoulder' with his people. He's passionate about the industry he works in and the therapies his team are developing for patients. The energy he brings is infectious and this shows in the incredibly successful career he's had to date.

Ed presents on a range of different courses for the SQA and he's also presenting at the 8th Car-TCR summit in Boston later this month. If anyone would like to know further information on these events, please check the links in the comments.

Hope you enjoy the show!

Welcome to Episode 1 of Season 1, of Let's Talk Quality: The Podcast.

Hemish was joined by Jaspreet Gill, Chief Quality Officer at Sangamo Therapeutics.

We discussed the incredible potential of cell and gene therapies and the role that quality leaders play in helping the industry reach its full potential.

• Transitioning from small molecule to cell and gene therapy
• The global potential of CGT, its impact on healthcare, and why it is exciting?
• The hurdles we will face which could slow down progression
• What companies can do to navigate the talent shortage
• Inspiring your people to create a patient centric culture
• Jas' experience of leading quality functions through BLA's
• Developing robust quality processes as companies scale up manufacturing

In addition to all of the above, we talk about Jas' outlook on leadership, advice for up and coming quality leaders, and what inspires her.

Jas' journey is inspirational and her authenticity and patient centric mindset shines through throughout the episode.

Hope you enjoy the show!

This is very special episode. I was joined by Laurie Adami, a financial services exec who was forced to give up her career after a cancer diagnosis in 2006.

After a 12 year battle fighting follicular non-Hodgkin lymphoma, and six lines of therapy, Laurie received a call from her oncologist, informing her about a new therapy called CAR-T, that was being developed by Kite Pharma.

They were opening a clinical trial at UCLA with five patients. Laurie was to be patient number one. One month after her CAR-T treatment, Laurie was in complete remission.

Laurie is now focused on patient advocacy, volunteering and fundraising for cancer research, especially CAR-T immunotherapy. 

I wanted to speak with Laurie, to talk about her fight against follicular non-Hodgkin lymphoma, how she learnt about a new game-changing therapy called CAR-T, and some key issues around access to patients, safety concerns raised by the FDA, bridging the gap between industry and patients, and what she is doing now to raise awareness of the benefits and potential of CAR-T. We discuss the following:

• [2:40] Laurie's Diagnosis, Initial Treatment and Challenges
• [5:00] 12 Year Cycle of Six Lines of Therapy and Relapse
• [10:55] Hearing the Story of Emily Whitehead and CAR-T in 2012
• [14:22] Starting Sixth Line of Therapy in 2016
• [14:57] Receiving a call about a CAR-T Trial in Spring, 2018
• [18:55] Going Through CAR-T Cell Therapy
• [21:32] Complete Remission
• [24:18] Becoming a Patient Advocate Volunteer
• [26:41] Patient Access and Challenges
• [35:41] Laurie's Response to the FDA Safety Advisory on CAR-T
• [41:30] Bridging the Gap Between Industry and Patients
• [46:16] The Potential and Future of CAR-T Therapy
• [51:34] Living Life to the Full
• [58:41] Meeting the People that Saved Her Life

I really hope people enjoy listening to Laurie's story and that it gives hope to anyone affected by Cancer, and raises awareness of the potential for CAR-T Cell Therapy to save more lives.

There are a number of challenges that Laurie is on a mission to tackle, and I would urge people to listen to this episode to learn more about how we can bridge the gap between the industry and patients, and get safter, faster and more affordable access of these therapies to more patients like Laurie.

Thank you Laurie for sharing your story with us!

In this conversation, Kimberly Wallbank, a quality systems consultant in the pharma & biotech industry, shares her insights and experiences in the world of contracting. She discusses the changes in the contracting market, the types of projects she takes on, and the shift towards remote and on-site work. Kimberly also provides advice on building a network and finding contracts, including the importance of volunteering and referrals. She emphasizes the need for flexibility, problem-solving skills, and a strong support system when starting out in contracting.

• Kimberly's Background and Consulting Work
• Reasons for Getting into Contracting
• Changes in the Contracting World
• Types of Projects and Team Sizes
• Shifts in Remote and On-Site Work
• Building a Network and Finding Contracts
• Volunteering and Referrals
• Dealing with Slowdowns in the Market
• Skills Needed for Consulting
• Motivation and Enjoyment as a Consultant
• Advice for Starting Out in Contracting

This is a conversation which is worth listening for anyone considering become a contractor. The contracting market has seen changes, with more consultants entering the market and building a network and proactively finding contracts can be a challenge without the right support systems. Kimberly shares how flexibility, problem-solving skills, and the ability to adapt to different business models are important for success as a consultant.

Hope you enjoy the show!

This week I speak with Stan Russell, who explains how quality leaders can create a function that adds true value to an organisation.

Stan provides practical advice for leaders to change perceptions and measure the strength of a quality culture. He also shares his leadership style and the importance of storytelling and analogies in articulating quality to the organisation, which can result in a function that is seen as truly valuable. We discuss the following:

• What is a 'Quality Culture' and why is it important?
• Evolution of the perception of quality
• How to measure the strength of a quality culture
• Practical steps for changing perceptions
• Utilizing management review to enhance your value
• How to facilitate team development
• Stan's leadership style and analogies he has used to communicate
• Advice for future quality leaders
• The 'one' soft-skill that Stan would advise leaders to develop

This is a fascinating insight into how quality leaders can ensure they are creating a function that puts people and the patient first, whilst enhancing the value and perception of the quality function within their organisation.

Stan is a true leader with an exceptional track record of quality leadership in enterprise and start-up organisations. A huge thank you for coming on the show.

This week I was joined by Vaishali Shukla, VP of Global Quality Manufacturing at Kite Pharma.

"Act locally but think globally”. This is the mindset that Vaishali has helped instil in her role to help harmonize processes, engage the global network, and create a 'one team' quality approach.

Vaishali talks us through her journey in quality and some of the challenges of leading a global quality operation of 500+ people, and the key aspects which have helped her to get to where she is now. We discuss the below points:

• The challenges of managing a global quality operation.
• Navigating the pandemic and transitioning into a remote world.
• Managing people in time-zones across the US, Europe, and Asia.
• Staying relevant with guidelines across different jurisdictions.
• Balancing compliance and innovation in the cell therapy industry.
• How to manage M&A and the complex transition that takes place.
• The evolution of guidelines and technology over the past two decades.
• How to stay relevant in a constantly evolving landscape.
• The skills Vaishali has developed to progress to where she is now.
• Vaishali's outlook on leadership, and within the ATMP space.

Whether you want to work in a global operation or small biotech, this is a must listen for any current or aspiring quality leader. So many great insights into the mindset of a highly successful quality leader and some key traits to help accelerate your own leadership career.

I hope you enjoy the show!

As a biotech professional, how do you know that the questions you ask 'experts' are accurate?

Is the answer based on explicit regulations? Or is it based on personal opinion, which has been formed by historical organisational practise?

In this episode, Greg Furrow, Chief Quality Officer of Mustang Bio, discusses his mission to raise awareness around the importance of industry 'experts' providing accurate and evidence-based information, rather than relying solely on personal experience or company practice.

As a recognised 'expert' himself, Greg talks about organisations and individuals giving disclaimers about their opinions. He encourages both experts and learners to prioritize understanding compliance and to seek the facts rather than blindly trusting opinions. We discuss the following:

• The Importance of Understanding Compliance
• The Risk of Mistakes and Misinformation
• Clear Regulations in the Biotech Industry
• Answering Compliance Questions in ATMP's
• The Goal of Understanding Compliance
• Obligations of Leaders in Answering Questions
• Advice for Future Quality Assurance Professionals
• What Inspires Greg in his Career.

Huge thanks to Greg for sharing his views and raising awareness around this important matter. Greg is on a mission to move away from giving subjective personal opinions based on organisational practises - towards a compliance framework anchored in explicit regulations and guidance documents.

Enjoy the show!

This is a story about the journey of commercialization for BMS' first cell therapies approved for the treatment of blood cancer.

Jason 'Jake' Treese, played a critical role in the development, approval and commercialization of Abecma and Breyanzi; two cell therapies which have now treated 4,700 patients in clinical and commercial settings - patients that are often on their last line of treatment, and last hope of a successful treatment.

We discuss leading the quality function in CAR-T cell therapy, the challenges faced in gaining approval for these therapies, the background of CAR-T cell therapy, the importance of building a strong team, the setbacks encountered during the approval process, and the motivation and inspiration behind the work. 

• Understanding CAR-T Cell Therapy
• Leading the Quality Function in CAR-T Cell Therapy
• Building the Team and Planning for Success
• Challenges and Setbacks in the Approval Process
• Maintaining Motivation and Mission
• The Approval and Reflections
• Advice for Quality Leaders in Cell Therapy
• Considerations for the Industry
• Reflections on the Impact of Cell Therapy

It's an incredible, emotional, and highly insightful story. For anyone that is leading an organisation through clinical development, particularly within cell therapy, this is a must listen!

This week on the podcast I speak with Emily English, VP of Quality at Cartesian Therapeutics.

Cartesian is a clinical-stage biopharmaceutical company developing RNA cell therapies designed to benefit the wide range of patients with cancer, autoimmune diseases, and respiratory diseases. We discussed RNA cell therapy and how Cartesian are bringing forward their mission of developing safer cell therapies for patients with autoimmune diseases. We talk about the following in detail:

• The work Cartesian are doing in RNA cell therapy and why it is exciting for patients.
• How early data suggests that Cartesian's lead programme can provide durable therapeutic benefit to patients with autoimmune diseases.
• Why Cartesian brought manufacturing in-house, the implications and the benefits of internal manufacturing.
• The transition in thinking and managing for risk and potential downtimes in the future versus planning for success.
• The challenges of bringing autologous cell therapies to patients at scale.
• Creating scalable processes for commercialisation, ensuring sustainability, and streamlining quality processes.
• At which stage in clinical development should organisations be thinking about creating scalable processes.
• How Cartesian are changing the way traditional cell therapies are developed and the implications of these changes.
• Emily’s values, her outlook on leadership, and what inspires her.

It was a pleasure to speak with Emily. It’s hugely exciting to see the incredibly innovative work that her and the team at Cartesian are doing to help patients suffering from autoimmune diseases. I’m looking forward to seeing the progress that Emily and her team make in bringing these therapies closer to the patients as they scale in a commercial setting.

We will definitely have another conversation in 12 months time to see how things are progressing at Cartesian!

I hope you enjoy the show!

The volume of data integrity violations cited in FDA warning letters has risen alarmingly over the last decade.

Several examples of poor data integrity practises have demonstrated the consequences it can have on a biotech's future, particularly when is occurs at an early stage of development.

In episode 11 of Let's Talk Quality, I was joined by Brian Furmanski, Chief Regulatory Officer for Kriya Therapeutics.

Brian has a large remit, covering regulatory, quality and clinical, and is passionate about all things data. He speaks about his background with the FDA, his journey to Kriya, and how he is implementing a culture of data integrity in his current role. We discuss the following:

• The importance of data integrity in pharma and biotech.
• What does good data integrity look like?
• How Brian drives a culture of data integrity in his current role.
• Data integrity gone wrong - real life examples.
• The consequences of poor data integrity practises.
• When biotech's should be thinking about developing more robust quality systems.
• How to start building better data integrity practises into your business.
• The challenges of overseeing multiple functions in a start-up biotech.

Huge thanks to Brian for joining us on the show and sharing some best practises for implementing great data integrity practises. For a biotech leader, especially if you're in preclinical studies, ensuring you are implementing and embedding a culture that drives data integrity excellence is paramount to your future success.

I hope you enjoy the show!

Today I spoke with Sonia Razzetti, SVP of Quality at Disc Medicine, a clinical stage biotech focussed on developing therapies in the haematology space. Sonia shares her journey in quality and discusses the challenges she faced, including finding her voice in leadership meetings and aligning quality objectives with business priorities. Sonia is really open about the failures she has had to overcome which have helped her develop her career and others.

Takeaways

• Finding your voice in leadership meetings
• Aligning quality objectives with business priorities are common challenges.
• The most rewarding aspects of working in quality.
• The value of listening more and speaking less for quality leader
• The importance of diverse perspectives and better decision-making.

 Chapters

• 00:00 Introduction and Background
• 03:38 Building a Late Phase/Commercial Ready Quality Management System
• 06:32 Transitioning from Big Pharma to Start-ups
• 10:44 Key Challenges Faced in Career Development
• 15:26 Finding Your Voice and Building Confidence in Leadership
• 20:37 Aligning Quality Objectives with Business Priorities
• 23:06 Shaping Leadership Approach and Mentoring Others
• 24:55 Evolution of Quality as a Profession
• 26:52 Pride in Career Achievements and Future Excitement
• 32:36 Advice for Aspiring Quality Leaders

Huge thank you to Sonia for coming on the show and being very open about the challenges she faced in her early career and how she managed to overcome these.

Hope you enjoy the show!

In today's episode I was joined by Markus Gruell, SVP Quality at Autolus Therapeutics, a late stage clinical development CAR-T cell therapy company headquartered in the UK.

Marcus, shares his journey in the industry and his role as VP of Quality at Autolus. We talk about his transition into the cell and gene therapy field and the challenges and opportunities it presents and move into his experience at Autolus, where he started as an associate director and worked his way up to SVP of Quality. Markus discusses the challenges faced by Autolus in their journey from a start-up to a commercial cell therapy company, the impact of COVID-19 and Brexit on their operations, as well a the transition from a paper-based QMS to an electronic QMS (EQMS) and the importance of having flexible systems.

• Transitioning into the cell and gene therapy field requires a steep learning curve
• The need for having the ability to work in a fast-paced, evolving environment.
• The importance of flexibility, adaptability, and collaboration
• The transition from a paper-based QMS to an EQMS
• The impact of COVID-19 and Brexit posed challenges for Autolus
• How patient impact is the driving force for Autolus
• How they strive to provide the best safety and efficacy data
• Essential qualities for quality leaders

Chapters

• 00:00: Introduction and Overview
• 05:04: Getting into Science and Quality Role
• 09:06: Differences in Quality Practices Between Countries
• 13:34: Transitioning into the Cell and Gene Therapy Field
• 19:25: Implementing Quality Systems at Autolus
• 23:26: Transitioning to an Electronic QMS
• 26:38: Challenges of COVID-19 and Brexit
• 30:43: Patient Impact in Cancer Treatment
• 34:35: Preparing for Pivotal Trials and Commercialization
• 37:28: Looking Ahead: Excitement for Commercialization
• 39:14: Values to Live and Die By
• 41:50: Leaving a Legacy
• 44:05: Advice for Future Quality Leaders

Thank you Markus for sharing your incredible journey and excited to see you and your teams work come to fruition.

I hope you enjoy the show!

Markus Gruell | LinkedIn

In today's episode I'm joined by Laura Malagon, VP Quality and Regulatory at Grand River Aseptic Manufacturing.

Laurie (as she is known as to those close to her) recently relocated from Miami to Michigan to lead the quality organisation at GRAM. She's had a fantastic journey in quality, starting her career washing glass-wear in a laboratory!

We talk about the following:

• Relocating from Miami to Michigan this year for a new VP role.
• Laurie's journey into science and quality.
• Working with different modalities, therapeutics and organizations.
• Laurie's love for quality and why she still has a passion for the industry.
• How the industry has evolved since she started.
• Communicating and leading cross-functionally.
• Moving from established organization to start-up.
• Laurie's hope for the future
• Advice for quality professionals
• The one person who inspired her the most.

Laurie's story should give inspiration to a lot of people in the early stages of their quality career that would like to progress into a Head of Quality one day.

She is kind, generous and incredibly passionate about leadership, quality and bringing safer medicines to patients. She's shown resilience throughout her career which has allowed her to widen her remit and grow her career. Her ambition to further her career shines throughout this conversation.

Thank you Laurie for sharing your incredible journey from washing glass-wear all of those years ago to where you are now!

Excited to see you continue to impact lives in your career.

Hope everyone enjoys the show!

In today's episode I was joined by James Myers, VP Quality at Spyre Therapeutics.

I wanted to speak with James about his journey, starting in GCP focussed roles and learn how he transitioned into all encompassing GxP position. As a result James has gained exposure across GCP and GMP and developed himself as a true GxP quality professional.

We discuss the following:

• Transitioning from GCP to GMP.
• Industry Trends.
• Gaining GMP Experience.
• Advancing to VP from director.
• Building a Team and Pilot Plant.
• Collaboration with Stakeholders.
• Gaining Organizational Buy-In.
• Importance of Listening.
• Strategic Thinking.

'Jim' is a great leader and most importantly a genuinely nice human being that has impacted people throughout his career in pharma and biotech. He is a credit to the industry and I'm sure his journey will inspire others to follow in his footsteps!

Thank you Jim for sharing your journey with us!

Hope everyone enjoys the show.

Today I'm joined by Kelly O'Hare, current Vice President, Head of Quality at enGene, an innovative biotech developing a very exciting non-viral gene therapy focussed on bladder cancer.

Kelly shares her journey in quality, discussing her transition from a technical writer to a quality leader. We talk about the importance of quality leaders being able to articulate the value of quality to their organizations. Her insights provide valuable lessons for aspiring quality professionals and leaders.

Takeaways

• Kelly's journey into quality began unexpectedly from a background in broadcast journalism.
• Mentorship played a crucial role in shaping her leadership philosophy.
• Building confidence in decision-making is essential for quality leaders.
• Quality should be defined in terms of efficiency and safety.
• User feedback is vital for successful quality system implementation.
• Quality management systems should be tailored to the organization's needs.
• Evolving perceptions of quality have led to greater appreciation from leadership.
• Inspiring passion for quality involves recognizing individual interests.
• Legacy is defined by the success of those you mentor and support.
• Future quality leaders should be confident yet flexible in their decision-making.

Chapters

• 00:00 Introduction to Quality and Career Journey
• 02:55 Transitioning from Science to Quality Leadership
• 06:03 Building Confidence in Quality Decisions
• 08:52 Defining and Articulating Quality
• 11:59 The Importance of Quality Management Systems
• 14:58 User Feedback and Quality System Implementation
• 17:59 Evolving Perceptions of Quality in Organizations
• 20:55 Inspiring Passion for Quality in Teams
• 23:50 Legacy and Mentorship in Quality Leadership
• 27:02 Final Thoughts and Advice for Future Leaders

This is a great conversation about the significance of defining and articulating quality to your organisation and the benefits this brings.

Thank you Kelly for joining us on the show!

In today's episode I was joined by Andrew Cieri, Senior Director of Quality for Regeneron's newly acquired cell therapy unit.

Regeneron are launching a new cell therapy unit after the acquisition of the pipeline and commercialisation rights to 2seventy products and Andrew has been tasked with launching this unit! I wanted to talk with Andrew to learn about his journey and how he's gone developing himself - both as a quality professional and leader.

Chapters

• 00:00 Introduction and Background
• 03:58 Early Interest in Science and Technology
• 07:56 Transition from Manufacturing to Quality
• 11:14 Transition into Leadership in Quality
• 22:58 Impact on Product Quality and Reflections
• 28:03 Current Focus and Future Plans
• 34:12 Values for Success in Quality Assurance
• 36:39 Leaving a Legacy and Advice for Future Leaders
• 39:23 Conclusion and Contact Information

Throughout his career, Andrew has been proactive, from transitioning into quality from manufacturing to going back to school to do a Masters in Engineering Management to develop his leadership skills. He's shown self-awareness throughout his career and still to this day is always looking to improve himself as a leader.

Thank you for joining us, Andrew, and looking forward to seeing all the amazing work you and your team do for patients in the future.

In today's episode, we're joined by Gary Barrera, Senior Vice President of Quality and Regulatory at Vera Therapeutics.

Gary shares that his love for reading and learning, as well as his curiosity about how things work, led him to pursue a career in science. He started in manufacturing and eventually moved into quality, where he discovered his passion for ensuring the reliability and safety of products. We talk about the benefits of gaining exposure to different areas of an organization and how that has helped Gary become the leader he is today!

We discuss the following:

• The evolution of quality in the industry.
• The importance of a strong quality culture .
• The advancements in data integrity.
• Addressing fraud in the industry.
• Importance of crisis management.
• Learning what & how your operational partners do.
• Collaborating effectively.

Chapters

• 00:00 Introduction and Podcast Inspiration
• 02:56 Getting into Science and Transitioning into Quality
• 07:12 The Role of Change Control in Gary's Quality Journey
• 09:34 The Importance of Quality Culture and Data Integrity
• 24:37 Pivotal Moments in Gary's Career Journey
• 35:40 Important Values and Advice for Future Quality Leaders

A huge thank you to Gary for joining us!

Hope you enjoy the show!

In today's episode, I'm joined by Andrea Goddard, former Chief Quality Officer at Genentech.

Andrea shares her career journey and insights into quality leadership. She started in biotech manufacturing and transitioned into quality after a conversation with her boss! Andrea emphasizes the importance of building strong relationships between quality and other departments within an organization. She discusses the challenges and rewards of working in a global role, including managing different time zones and cultures.

We cover:

• Building strong relationships between quality and other departments.
• Managing different time zones and cultures.
• The importance of respect, authenticity, and work ethic.
• Using data to make informed choices.
• Putting yourself outside of your comfort zone.

A huge thank you to Andrea for joining us on the show and for giving us her time. She's had an incredible 30-year career with Genentech/Roche, starting in 1995, and positively impacting so many lives along the way.

Hope you enjoy the show!

Sean Smith, Vice President and Head of Quality at KSQ Therapeutics, shares his journey from working in big biotech to transitioning into small biotech and the challenges and opportunities that come with it.

He emphasizes the importance of being willing to challenge the status quo, having an openness to learning, and practicing empathy as a quality leader.

Smith also discusses the need for quality to be seen as an asset and the importance of building empowered and diverse teams. He encourages aspiring quality leaders to become experts in one or two areas to differentiate themselves.

Takeaways: 

• Be willing to challenge the status quo and ask why things are done a certain way.
• Have an openness to learning and constantly strive to improve.
• Practice empathy and build relationships to create a positive quality culture.
• View quality as an asset and strive to integrate it early in the product realization process.
• Differentiate yourself as a quality leader by becoming an expert in one or two areas.

In this episode, I had the privilege of speaking with Matthew Wheeler, Vice President of Quality and Clinical Operations at Precision BioSciences.

Matthew’s journey is nothing short of inspiring. From starting his career in food manufacturing at Kellogg's to building a career in biotech, his story is one of resilience, adaptability, and leadership.

In the past year, Matt was diagnosed with not one, but three rare diseases, including GPA vasculitis and IgA nephropathy.

Despite these challenges, he continues to lead with strength, empathy, and gratitude.

We covered a lot of ground in this conversation, including:

• Transitioning from food manufacturing into biotech and navigating the early challenges of his career.
• The breadth of experience gained that shaped his expertise.
• The importance of mentors and leadership in personal and professional growth.
• Building a quality function at Precision BioSciences and integrating quality into R&D operations.
• His personal health challenges and how they've influenced his outlook on life and leadership.
• His commitment to service, gratitude, and family as guiding principles in his life.

Matthew’s candidness about his recent health challenges and their impact on his perspective was incredibly moving.

Thank you, Matt, for sharing your story with such honesty and vulnerability. It’s leaders like you who remind us of the impact that Life Science professionals have on patients’ lives.

I hope you enjoy hearing Matt’s story as much as I did—it’s one you won’t forget!

In this conversation, Lauren Smith, Chief Quality Officer at OrcaBio, shares her journey into the field of quality assurance, discussing her early career, leadership experiences, and the importance of connecting work to patient outcomes. She emphasizes the challenges and rewards of working in quality assurance, the significance of practical quality, and the need for purpose-driven leadership. Lauren also highlights the importance of employee development, self-awareness, and the impact of pivotal moments in her career.

Takeaways:

• Lauren fell into quality assurance rather than choosing it intentionally.
• Her early experiences in environmental monitoring were invaluable for her career.
• Quality roles allow for direct impact on patient safety and product quality.
• The quality assurance field is constantly evolving and challenging.
• Lauren values authenticity, integrity, and kindness in her leadership.
• She emphasizes the importance of connecting work to a greater purpose.
• Practical quality and team dynamics are crucial for success in quality assurance.
• Employee development should be tailored to individual goals and needs.
• Self-awareness is key to effective leadership and personal growth.

Lauren believes in leaving a quiet legacy through her interactions with others.

For anyone looking to learn about how to hire great people, build a purpose driven culture, and develop their people, this is a great episode to listen to!

Thank you Lauren for joining us!

Hope everyone enjoys the show!

On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Swetha Krishnan, Executive Director and Head of Quality at Mural Oncology, a fast growing biotech in Waltham, Massachusetts.

Here's what they discuss:

• How Swetha's upbringing shaped her career progression 🚀
• Moving from India to the US to pursue a career in science 🧬
• Why wearing so many hats early on improved her confidence 👏
• Why you don't always need all of the answers 🗯️
• Balancing technical expertise with emotional intelligence ✴️
• Learning to be adaptable and removing biases ✔️
• How to develop and build credibility as a leader🔥

If you’re an aspiring leader, this episode will help you understand some of the key traits and characteristics to focus on to reach your full potential as a people leader.

Huge thank you to Swetha for joining us on 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!

On this week's episode of Let's Talk Quality: The Podcast🎙️Hemish Ilangaratne is joined by Sang Yoon, VP of Quality Assurance at ImmunityBio, a cell and gene therapy company based in California.

Sang’s story is truly inspiring. With 25+ years in biologics, medical devices, and healthcare, he’s been at the forefront of product launches, recalls, and scaling operations globally. But what stood out to me most was his approach to leadership:

✅ Build a community first

✅ Lead with trust, self-awareness, and adding value

✅ Create a culture where people thrive, learn, and grow

Sang shared so many practical tips for quality leaders, especially around shaping culture in the first 90 days of a role and developing your leadership style:

1. Build relationships across all levels of the team
2. Be self-aware: your actions and words influence culture
3. Focus on developing learning organizations
4. Add value to your people—find ways to help them thrive

We also talked about Sang’s experiences transitioning from sponsor companies to CDMOs and what really excites him about ImmunityBio’s journey.

If you’re an aspiring leader, there’s so much to take from this conversation. Thank you, Sang, for sharing your insights! 🎙️

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!

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.

🎙️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 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. 

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 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!

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!

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!