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.