Let's Talk Quality

Forty seven years in quality, and Tim Mitchell says the job he started is nothing like the one he does today. Tim Mitchell on how quality stopped being black and white In today's episode I was joined by Tim Mitchell, Vice President of Quality at Aktis Oncology, a radiopharmaceutical company in Boston developing treatments across several types of cancer. I really wanted to speak to Tim because very...

She came to the US with her first year's tuition and figured the rest out from there. What followed is one of the most grounded quality leadership journeys I have heard - and one we felt was worth bringing back. Swetha Krishnan on Building a Quality Mindset from the Ground Up This is a rerelease of one of our favourite episodes from two years ago. In today's episode I was joined by Swetha Krishnan...

What does it really take to build a quality organization from the ground up - and do it again, and again, across multiple companies? Laura Singer on building quality that scales. In today's episode I was joined by Laura Singer, Vice President of Quality and Compliance at Loyal. I really wanted to speak to Laura because she has spent the better part of two decades walking into an early-stage biotec...

From the lab bench to the C-Suite - and every crisis in between. In today's episode I was joined by Kimberly Garko, former Senior Vice President and Chief Technical Officer at Akebia Therapeutics. I really wanted to speak to Kim because her career trajectory is unlike almost anyone else I have interviewed on this show. She is a PhD virologist who began her career in the QC lab at Biogen, and over...

Three BLAs. Three companies. One industry-defining challenge. Jake Trees, Irving Ford, and Megan Callan on What It Really Takes to Cross the Commercial Line in Cell and Gene Therapy In this special compiled episode of Let's Talk Quality, Hemish Ilangaratne brings together three quality leaders who have each led their organisation through one of the most demanding transitions in the industry: from...

The non-linear path is often the most powerful one. Cinta Burgos on Building a Career Across Functions, Modalities, and Mindsets. In today's episode I was joined by Cinta Burgos, Senior Vice President of Quality and Regulatory CMC at New Amsterdam Pharma. I really wanted to speak to Cinta because her career does not follow the path you might expect for someone at SVP level. She has moved across ph...

From a graveyard shift in a generic drug lab to leading quality for one of the most advanced cell therapy programs on the planet - Mike Ruane's story is one every quality professional needs to hear. In today's episode I was joined by Mike Ruane, Head of Quality for In Vivo CAR-T at Bristol Myers Squibb. I really wanted to speak to Mike because his career is one of the more fascinating journeys I h...

CAR-T Saved Her Life. Why Can’t Most Patients Access It? In today’s episode I was joined by Laurie Adami, cancer survivor, patient advocate, and one of the most impactful voices I’ve had on the podcast. I first spoke to Laurie a couple of years ago, and her episode is still one of the most listened to we’ve had. Laurie went through a 12-year cancer journey, six lines of therapy, multiple relapses,...

Perseverance, perspective and people-first leadership in a global quality role. In today's episode I was joined by Burak Begen, Head of Global Manufacturing Quality at Siemens Healthineers. I really wanted to speak to Burak because he’s built his career across multiple countries, cultures and challenges, and now leads quality across global manufacturing sites. His journey gives a very real view of...

Great quality leaders don’t just build systems - they build people, culture and confidence. In today's episode I was joined by Melodie Bryce, Chief Quality Officer at Kincell Bio. Melodie’s journey is a brilliant example of how diverse experience across manufacturing, supply chain, training and quality can shape a well-rounded quality leader What stood out most is her approach to leadership. Melod...

If you are the first quality hire in a startup, your job is not to build everything at once. Your job is to build the right things first. That was one of the clearest takeaways from my conversation with Rex Ready on Let’s Talk Quality. A few practical points he shared stood out: · Follow the path of the product · Understand the patient experience · Focus first on what directly affects patient safe...

Quality is changing. The systems are getting smarter, the data is getting bigger, and the people side is still the hardest part. This week, I sit down with Dennis Rodman, Senior Director of Quality Management Systems and Digital Compliance at Intellia Therapeutics. Dennis brings a rare perspective to quality. With 13 years at BMS across operations, technical services, and quality, he now helps a g...

From accidental quality professional to global quality leader - Valerie Brown's story is one of courage, curiosity, and conviction. In today's episode I was joined by Valerie Brown, Head of Global Quality Assurance and Compliance at Thermo Fisher Scientific's Clinical Research Group. I really wanted to speak to Valerie because she brings something different to the quality leadership conversation....

What if the leader you become is shaped less by your title, and more by the life you’ve lived? In today's episode I was joined by Dana Adcock, Quality Consultant and former Senior Director of Quality Systems. I really wanted to speak to Dana because she brings something different to the quality leadership conversation. Yes, she has decades of experience leading global audit and quality systems tea...

In today’s episode, Hemish was joined by Anthony Mire-Sluis, Head of Global Quality at Gilead. Tony because has lived quality from every angle - UK government and regulatory work, a stint at the FDA, and then senior global leadership roles in major pharma. That perspective is rare, and it shows in how he builds teams and drives change. Tony’s journey is a brilliant example of how strong quality le...

In today’s episode, Hemish was joined by Ed Armstrong and Jon Voss, two Quality leaders who’ve both worked across early-stage, clinical, and complex biotech environments. Ed and Jon share what they’re seeing on the ground - from funding pressure and modality shifts, to how regulators are engaging, and where Quality leaders are gaining (or losing) influence. They talk about the following: The curre...

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...