“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 their knowledge, experiences, and strategies for achieving quality excellence. Join us on a journey of discovery as we unravel the im...
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Nov 13, 2026 · 6:28
This is Small Dose, our weekly series of short clips from Let’s Talk Quality. This week’s clip is from Episode 4 of Season 1, with Amnon Eylath. Listen to the full episode on:…
Nov 6, 2026 · 4:53
This is Small Dose, our weekly series of short clips from Let’s Talk Quality. This week’s clip is from Episode 3 of Season 1, with Ann Farnsworth. Listen to the full episode on:…
Oct 30, 2026 · 4:18
This is Small Dose, our weekly series of short clips from Let’s Talk Quality. This week’s clip is from Episode 2 of Season 1, with Ed Armstrong. Listen to the full episode on:…
Oct 23, 2026 · 4:22
This is Small Dose, our new weekly series of short clips from Let’s Talk Quality. This week’s clip is from Episode 1 of Season 1, with Jaspreet Gill. Listen to the full episode…
Oct 6, 2026 · 50:41
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…
Sep 29, 2026 · 41:13
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.…
Sep 22, 2026 · 41:12
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…
Sep 11, 2026 · 36:06
Naymisha (Isha) Patel has spent thirty years in Quality and regulatory compliance across pharmaceuticals, biologics, medical devices and combination products. She is now Senior…
Sep 1, 2026 · 39:02
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.…
Aug 25, 2026 · 39:13
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.…
Jul 30, 2026 · 16:46
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…
Jul 21, 2026 · 38:26
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…
Jul 14, 2026 · 29:33
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…
Jul 7, 2026 · 33:44
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…
May 26, 2026 · 41:01
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…
May 19, 2026 · 35:29
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.…
May 12, 2026 · 37:02
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…
May 7, 2026 · 34:54
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…
Apr 28, 2026 · 28:28
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,…
Apr 21, 2026 · 35:26
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…
Apr 14, 2026 · 38:09
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…
Mar 31, 2026 · 29:59
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…
Mar 24, 2026 · 25:56
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…
Mar 17, 2026 · 31:33
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…
Mar 10, 2026 · 30:44
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…
Mar 3, 2026 · 31:50
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…
Feb 24, 2026 · 33:04
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…
Feb 17, 2026 · 37:22
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…
Feb 10, 2026 · 41:46
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…
Dec 10, 2025 · 34:43
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…
Dec 3, 2025 · 42:23
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…
Nov 26, 2025 · 30:12
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…
Nov 12, 2025 · 33:00
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…
Nov 5, 2025 · 38:26
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…
Oct 29, 2025 · 40:28
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,…
Oct 15, 2025 · 45:58
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…
Oct 8, 2025 · 38:50
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…
Oct 1, 2025 · 48:02
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,…
Sep 10, 2025 · 57:18
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…
Aug 27, 2025 · 44:08
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…
Aug 20, 2025 · 36:44
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…
Aug 13, 2025 · 46:15
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…
Aug 6, 2025 · 43:08
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…
Jul 30, 2025 · 54:16
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…
Jul 23, 2025 · 59:44
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…
Apr 16, 2025 · 39:40
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,…
Mar 19, 2025 · 43:02
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…
Mar 12, 2025 · 56:54
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,…
Mar 5, 2025 · 50:52
🚀 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…
Feb 19, 2025 · 35:38
🎙️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…
Feb 12, 2025 · 32:38
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…
Feb 5, 2025 · 44:02
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…
Jan 22, 2025 · 45:44
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…
Jan 15, 2025 · 47:42
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,…
Dec 18, 2024 · 28:54
On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Hanh Nguyen , Site Head of Quality at Minaris Regenerative Medicine , a global CDMO…
Dec 11, 2024 · 33:32
On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Sang Yoon , VP of Quality Assurance at ImmunityBio , a cell and gene therapy company…
Dec 4, 2024 · 48:24
On this week's episode of Let's Talk Quality: The Podcast🎙️ Hemish Ilangaratne is joined by Swetha Krishnan , Executive Director and Head of Quality at Mural Oncology , a fast…
Nov 27, 2024 · 44:44
In this episode, I had the privilege of speaking with Matthew Wheeler, Vice President of Quality and Clinical Operations at Precision BioSciences. Matthew’s journey is nothing…
Nov 20, 2024 · 37:02
In this conversation, Lauren Smith, Chief Quality Officer at OrcaBio, shares her journey into the field of quality assurance, discussing her early career, leadership experiences,…
Nov 13, 2024 · 34:24
Sean Smith, Vice President and Head of Quality at KSQ Therapeutics, shares his journey from working in big biotech to transitioning into small biotech and the challenges and…
Nov 6, 2024 · 36:48
In today's episode, I'm joined by Andrea Goddard, former Chief Quality Officer at Genentech. Andrea shares her career journey and insights into quality leadership. She started in…
Oct 31, 2024 · 42:23
In today's episode, we're joined by Gary Barrera, Senior Vice President of Quality and Regulatory at Vera Therapeutics. Gary shares that his love for reading and learning, as…
Oct 23, 2024 · 41:10
In today's episode I was joined by Andrew Cieri, Senior Director of Quality for Regeneron's newly acquired cell therapy unit. Regeneron are launching a new cell therapy unit…
Oct 10, 2024 · 30:51
In today's episode I'm joined by Laura Malagon, VP Quality and Regulatory at Grand River Aseptic Manufacturing. Laurie (as she is known as to those close to her) recently…
Oct 2, 2024 · 30:35
In today's episode I was joined by James Myers, VP Quality at Spyre Therapeutics. I wanted to speak with James about his journey, starting in GCP focussed roles and learn how he…
Sep 25, 2024 · 46:09
Today I'm joined by Kelly O'Hare, current Vice President, Head of Quality at enGene, an innovative biotech developing a very exciting non-viral gene therapy focussed on bladder…
Sep 18, 2024 · 46:09
In today's episode I was joined by Markus Gruell, SVP Quality at Autolus Therapeutics, a late stage clinical development CAR-T cell therapy company headquartered in the UK.…
Sep 11, 2024 · 36:18
Today I spoke with Sonia Razzetti, SVP of Quality at Disc Medicine, a clinical stage biotech focussed on developing therapies in the haematology space. Sonia shares her journey…
Sep 4, 2024 · 37:15
We are back for Season Two of Lets Talk Quality! This week, I had the pleasure of speaking with Irving Ford, VP of Quality at Adaptimmune Therapeutics. Irving has been through…
Mar 13, 2024 · 38:22
Joe Franchetti, President of the Society of Quality Assurance (SQA), shares his vision for the SQA and the wider quality assurance industry, emphasizing the importance of…
Feb 22, 2024 · 1:02:02
This is very special episode. I was joined by Laurie Adami, a financial services exec who was forced to give up her career after a cancer diagnosis in 2006. After a 12 year…
Feb 15, 2024 · 31:01
In this conversation, Kimberly Wallbank, a quality systems consultant in the pharma & biotech industry, shares her insights and experiences in the world of contracting. She…
Feb 7, 2024 · 38:22
This week I speak with Stan Russell, who explains how quality leaders can create a function that adds true value to an organisation. Stan provides practical advice for leaders to…
Jan 30, 2024 · 27:07
This week I was joined by Vaishali Shukla, VP of Global Quality Manufacturing at Kite Pharma. "Act locally but think globally”. This is the mindset that Vaishali has helped…
Dec 20, 2023 · 33:38
As a biotech professional, how do you know that the questions you ask 'experts' are accurate? Is the answer based on explicit regulations? Or is it based on personal opinion,…
Dec 7, 2023 · 45:31
This is a story about the journey of commercialization for BMS' first cell therapies approved for the treatment of blood cancer. Jason 'Jake' Treese, played a critical role in…
Nov 29, 2023 · 30:10
This week on the podcast I speak with Emily English, VP of Quality at Cartesian Therapeutics. Cartesian is a clinical-stage biopharmaceutical company developing RNA cell…
Nov 9, 2023 · 30:29
The volume of data integrity violations cited in FDA warning letters has risen alarmingly over the last decade. Several examples of poor data integrity practises have…
Oct 26, 2023 · 37:30
This week I spoke with Jacob Patterson, VP quality for a clinical stage biotech in Rhode Island. Jacob, by his own admission, has had to continuously adapt, learn and be flexible…
Oct 13, 2023 · 35:24
This week, we spoke with Brian Nunnally, and discussed some of the challenges that Brian faced throughout his journey to where he is now, Global Head of QC at CSL. Brian is…
Oct 5, 2023 · 30:39
This week I was joined by Peggy Owens, Head of Quality at Kincell Bio, a CDMO operating in early phase cell therapy. Peggy has an extensive background in cell therapy, having…
Sep 28, 2023 · 35:40
On this weeks show, I speak with John McKay, a well respected, well loved and highly seasoned quality assurance leader in pharma and biotech across clinical development and…
Sep 21, 2023 · 35:46
Welcome to episode 6 of Let's Talk Quality. I was joined by Greg Whitehead. Greg is Head of Quality at Editas Medicine and has been working in biotech for 30 years, with a…
Sep 14, 2023 · 33:12
There are 6 female CEO's of biotech companies with a market cap of over $5bn. In this episode, I was lucky to speak with Christy, who is an incredible advocate for females in…
Aug 30, 2023 · 34:29
What exactly is 'phase-appropriate' quality? In episode 4 of Let's Talk Quality, I was joined by Amnon Eylath to discuss the origins of the well known term, 'phase-appropriate'…
Aug 23, 2023 · 27:48
Welcome to Episode 3 of Season 1, of Let's Talk Quality: The Podcast. Hemish was joined by Ann Farnsworth. Ann is the VP of Quality Assurance for C4 Therapeutics, a clinical…
Aug 16, 2023 · 27:31
Welcome to Episode 2 of Let's Talk Quality! Today's guest is Edward Armstrong. Ed is the VP of Quality at Mustang Bio. What stood out about the conversation with Ed was his…
Aug 9, 2023 · 31:54
Welcome to Episode 1 of Season 1, of Let's Talk Quality: The Podcast . Hemish was joined by Jaspreet Gill , Chief Quality Officer at Sangamo Therapeutics. We discussed the…
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