Loading...

PODCAST

Let"s Talk Quality

Hemish Ilangaratne

“Let’s Talk Quality” is a podcast that seeks to shine a light on quality assurance, a profession that acts as the cornerstone for bringing safer medicine to patients. For life science companies to continue to develop life-saving medicines, a culture of good quality must be driven across the industry, whether that be an early phase gene therapy biotech or a global pharma organisation. This podcast aims to drive that mission forward through inviting industry leaders, experts, and visionaries to share

science life sciences

All Episodes

41:13

Colleen Walson-Billin on Building a Quality Career...

Let"s Talk Quality ·

2026/09/29

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 speak to Colleen because her route into Quality started with a business degree and a role as administrative

en

41:12

Geetu Abbi on When to Build a Digital Quality Function

Let"s Talk Quality ·

2026/09/22

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 FunctionIn 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 systems validation. She moved from software testing into validation at Siemens without a life sciences

en

36:06

Isha Patel on the Overnight Career Plan That Took Her...

Let"s Talk Quality ·

2026/09/11

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 wrote overnight in 2005 after a hiring VP at Nektar asked what she wanted, and how it carried her from

en

39:02

Dawn Houlihan on Her Journey From Ireland Big Pharma...

Let"s Talk Quality ·

2026/09/01

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 done it across almost every stage and modality the industry has to offer. She spent half her career with

en

39:13

Luciana Mansolelli on Her First Year as CQO in the...

Let"s Talk Quality ·

2026/08/25

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 J&J on the sponsor side, and now a 200-person global quality organisation across the US, Germany and

en

16:46

My Thoughts on Quality Leadership, Halfway Through...

Let"s Talk Quality ·

2026/07/30

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 for your working relationships, which comes from the other half of my week, placing quality leaders and

en

38:26

Speaking the Language of the Business, with Jamey...

Let"s Talk Quality ·

2026/07/21

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 this industry can throw at you: a first-in-class FDA approval at Seres Therapeutics, an acquisition by

en

29:33

The Big Pharma Habits You Have to Unlearn in a...

Let"s Talk Quality ·

2026/07/14

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 speak to Dawn because her path is nothing like the typical quality leader's. She didn't stay inside big

en

33:44

How Quality Stopped Being Black and White, with Tim...

Let"s Talk Quality ·

2026/07/07

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 whiteIn 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 few people have watched quality evolve the way he has. He started in 1980, when the GMP regulations were

en

41:01

Swetha Krishnan on her journey from Individual...

Let"s Talk Quality ·

2026/05/26

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 UpThis is a rerelease of one of our favourite episodes from two years ago. In today's episode I was joined by Swetha Krishnan. I really wanted to bring this conversation back because Swetha's route into quality was entirely

en

35:29

Building Quality That Scales, with Laura Singer

Let"s Talk Quality ·

2026/05/19

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 biotech and building everything from scratch. Each time, a different product, a different regulatory landscape,

en

37:02

From Virologist to CTO: Leading Quality Through...

Let"s Talk Quality ·

2026/05/12

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 the following two decades built herself into one of the most accomplished quality and technical operations

en

34:54

Three BLAs, Three Journeys, with Irving Ford, Megan...

Let"s Talk Quality ·

2026/05/07

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 TherapyIn 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 clinical development to commercial manufacturing for a cell or gene therapy product.Jake Trees spent five

en

28:28

The Non-Linear Path to Quality Leadership, with Cinta...

Let"s Talk Quality ·

2026/04/28

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 pharma, medical devices, and biologics, held roles in quality engineering, validation, regulatory, and

en

35:26

From the Graveyard Shift to the Frontier of Cell...

Let"s Talk Quality ·

2026/04/21

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 have come across in quality leadership. He has spent nearly two decades within what is effectively the same

en

38:09

Laurie Adami on Life After CAR-T, and the Reality...

Let"s Talk Quality ·

2026/04/14

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, clinical trials… and ultimately, in 2018, her 7th treatment, CAR T-cell therapy which saved her life and

en

29:59

How to Drive KPI's the Right Way in Global Quality,...

Let"s Talk Quality ·

2026/03/31

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 what it actually takes to operate at that level.Burak’s career hasn’t been linear or easy. From starting

en

25:56

Developing Future A-Player Quality Leaders, with...

Let"s Talk Quality ·

2026/03/24

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 leaderWhat stood out most is her approach to leadership. Melodie focuses heavily on building strong teams, developing future leaders and creating an environment where

en

31:33

Lessons from Building Quality in Start-Up Cell...

Let"s Talk Quality ·

2026/03/17

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 safety· Build procedures around processes that already work· Prioritise quality investment based on stage,

en

30:44

What Good Digital Transformation in Quality Actually...

Let"s Talk Quality ·

2026/03/10

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 gene editing company prepare for its first commercial product.In this episode, we explore:Why quality

en

83 results

Similar Podcasts

Beyond the Divide

Koala Moon

The SCP Experience

Dr. NoSleep Studios

John Michael Godier"s Event Horizon

John Michael Godier

La Science CQFD

France Culture

A Moment of Science

Indiana Public Media