Let's Talk Quality

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.