Let's Talk Quality

Maja Pedersen says following a process is what she does least, and she built a career in Quality because a clear framework gives people room to make pragmatic decisions. Maja Pedersen on AI, Strategic Leadership, and Evolving as a Quality Leader In today's episode, we revisit a conversation with Maja Pedersen from July 2025. Maja is now President and Chief Operating Officer at FUJIFILM Biotechnolo...

Colleen Walson-Billin was told she was not eligible to progress in Quality without a science degree, and went on to lead a full GxP Quality function at a biologics startup. Colleen Walson-Billin on building a Quality career without a science degree. In today's episode I was joined by Colleen Walson-Billin, Vice President & Head of GxP Quality & Compliance at Jade Biosciences. I wanted to s...

Geetu Abbi was handed the GAMP guide as a new validation engineer at Genzyme, and in 2024 she co-led one. Geetu Abbi on When to Build a Digital Quality Function In today's episode I was joined by Geetu Abbi, Head of Digital Quality Assurance at Alkermes. I wanted to speak to Geetu because Digital Quality was not a job title eight to ten years ago, and she has grown into the role from computer syst...

Naymisha (Isha) Patel has spent thirty years in Quality and regulatory compliance across pharmaceuticals, biologics, medical devices and combination products. She is now Senior Vice President of Quality at AirNexis Therapeutics, a seven-month-old startup developing a combination product for COPD, where she is the first Quality hire. In this episode Isha talks about the ten-year career plan she wro...

Dawn Houlihan started out as the person manufacturing teams went quiet around, and spent the next twenty years proving that quality works better as a partner than a police force. Dawn Houlihan on Her Journey From Ireland Big Pharma to the Boston Start-Up World In today's episode I was joined by Dawn Houlihan. I wanted to speak to Dawn because she has built a quality function from nothing, and has...

Luciana Mansolelli spent twenty years on the sponsor side. One question from a board chairman moved her to a CDMO. Luciana Mansolelli on her first year as CQO in the CDMO world. In today’s episode I was joined by Luciana Mansolelli, Chief Quality Officer at Minaris Advanced Therapies. I wanted to speak to Luciana because she has now led quality on both sides of the same relationship - Novartis and...

Season Four is at its halfway point, so instead of a guest this week I’ve gone back over the conversations so far and pulled out the theme that came up most often. The quality leader whose main function is to say no is finished. This episode is four clips from Season Four guests on that theme, with my own thoughts in between. I also talk about why I think this matters for your career and not just...

Quality culture isn't built by SOPs. It's built in the small moments when a leader reinforces the right behaviour or lets the wrong one slide. Speaking the Language of the Business, with Jamey Lindholm. In today's episode I was joined by Jamey Lindholm, Vice President of Quality at R1 Therapeutics. I really wanted to speak to Jamey because she has led Quality through nearly every stage a career in...

Twenty years at Merck, then a leap into academia and psychedelic medicine - here is how Dawn Lundin built a quality career on instinct. Dawn Lundin on the big pharma habits you have to unlearn in a startup. In today's episode I was joined by Dawn Lundin, founder of her own quality consultancy and a fractional Head of Quality across biotech and psychedelic-medicine companies. I really wanted to spe...

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...