Let's Talk Quality

This week on Let’s Talk Quality, we’re joined by Elisabeth Hutchins, Senior Director of Quality at Upstream Bio , for a conversation focused entirely on one theme: How quality professionals make the transition from tactical execution to strategic leadership. In this episode, Elisabeth shares: What changes as a company enters Phase 2 and Phase 3 The moment she realised she needed to stop firefighti...

This week, Hemish is joined by Ashley Preston, SVP of Regulatory, Quality and Medical Writing at Blossom Hill Therapeutics, for a conversation about what it really takes to win hearts and minds early in quality leadership . Ashley took an unconventional path into QA, stepping into his first Quality leadership role after a long career in Regulatory Affairs. Because of that, he’s had to lead through...

From Greenfield to GMP. In today's episode, Hemish is joined by Kyle Powell, Head of Quality at Ratio Therapeutics. Kyle is a great example of the next generation of quality leaders who are building from the ground up - combining technical depth with a modern, empathetic approach to leadership. Kyle’s career is an impressive story of growth, moving from regulatory consulting into radiopharmaceutic...

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

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

 Andrew’s career spans 30+ years across b...

In today's episode, Hemish was joined by Theresa Donegan, VP of Quality at Climb Bio. Theresa has spent the last few years helping biotech startups build quality from the ground up - often as a team of one.  With 30 years’ experience across every GxP environment, she brings a rare perspective on what it takes to move from large pharma structure to biotech agility, while still protecting compl...

From £9,000-a-year QC analyst to global quality leader - Iain Rusling’s story is a masterclass in soft‑skills, grit and making quality a strategic enabler. In today's episode, Hemish was joined by Iain Rusling, a global Quality & Operations leader and former Chief Quality Officer. Iain's journey - from QC benches in the UK to leading international, matrixed teams in Europe, captures the mindse...

AI is here - and it’s already changing the way we think about compliance, quality, and productivity in biotech. In today's episode Hemish was joined by Subbu Viswanathan, Head of Compliance at DashBio. Subbu because is one of the few quality leaders who has been building and integrating AI into quality systems for over a decade – long before it was mainstream. And he’s now leading quality and comp...

In this episode, Hemish was joined by Karin von Hodenberg, VP of Quality at Monte Rosa Therapeutics. Karin has repeatedly built quality systems from the ground up across med device and biotech, and she translates that experience into practical, phase-appropriate guidance for early teams. Karin’s journey is anything but typical: a business background, supply chain and Lean Six Sigma Black Belt trai...

Creating order from chaos: how a VP of Quality builds trust, leads through constraints, and keeps teams focused on patients. In today's episode Hemish was joined by Sep Naraghi, Vice President of Quality & Regulatory Affairs at Cellularity Inc. Sep has led quality in both Big Pharma and startups and has a practical, people-first approach to building trust, making trade-offs, and delivering und...

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,...

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, A...

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 accelerate...

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 journ...

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 exam...

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 c...

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 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...

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 exte...

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 comme...

🚀 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 s...

🎙️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 h...

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...

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...

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 min...

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...