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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

35:38

Katarina Bartle’s Leadership Journey: No Network, No...

Let"s Talk Quality ·

2025/02/19

🎙️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 has shaped global teams and helped redefine how companies approach quality.In today’s episode of Let’s Talk

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32:38

Biana Torres on her transition into Cell & Gene...

Let"s Talk Quality ·

2025/02/12

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 a doctor, pivoted into biotech by accident, and has since built a career leading quality teams through

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44:02

Shane Ernst on Thriving as an Introverted Quality Leader

Let"s Talk Quality ·

2025/02/05

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 regulatory challenges.We talk about the following:🔹 How he accidentally fell into quality after starting

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45:44

Rob Dallimore on Overcoming Challenges and Building...

Let"s Talk Quality ·

2025/01/22

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 mindset required to pivot into new areas of expertise, how to build resilient teams, and his experience

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47:42

Jon Voss on making practical decisions that put...

Let"s Talk Quality ·

2025/01/15

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 the balance between pragmatism and patient safety.We talk about the following:The evolution of quality from

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28:54

Hanh Nguyen on Imposter Syndrome, Mental Health, and...

Let"s Talk Quality ·

2024/12/18

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 specializing in cell and gene therapies.Hanh’s career started in document control at Amgen, spending over a decade in Big Pharma, before taking a leap into smaller, fast-paced organizations.That move - stepping out of her comfort zone, was a pivotal moment that accelerated her growth and confidence as a leader.Hanh is a

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33:32

Sang Yoon on creating a community first, a company...

Let"s Talk Quality ·

2024/12/11

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 based in California.Sang’s story is truly inspiring. With 25+ years in biologics, medical devices, and healthcare, he’s been at the forefront of product launches, recalls, and scaling operations globally. But what stood out to me most was his approach to leadership:✅ Build a community first✅ Lead with trust, self-awareness, and

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48:24

Swetha Krishnan on her journey from Individual...

Let"s Talk Quality ·

2024/12/04

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 growing biotech in Waltham, Massachusetts.Here's what they discuss:How Swetha's upbringing shaped her career progression 🚀 Moving from India to the US to pursue a career in science 🧬 Why wearing so many hats early on improved her confidence 👏 Why you don't always need all of the answers 🗯️ Balancing technical expertise with

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44:44

Matthew Wheeler - a story of resilience and gratitude.

Let"s Talk Quality ·

2024/11/27

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 short of inspiring. From starting his career in food manufacturing at Kellogg's to building a career in biotech, his story is one of resilience, adaptability, and leadership.In the past year, Matt was diagnosed with not one, but three rare diseases, including GPA vasculitis and IgA nephropathy.Despite these challenges, he

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37:02

Lauren Smith on choosing a career that truly impacts...

Let"s Talk Quality ·

2024/11/20

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, and the importance of connecting work to patient outcomes.She emphasizes the challenges and rewards of working in quality assurance, the significance of practical quality, and the need for purpose-driven leadership. Lauren also highlights the importance of employee development, self-awareness, and the impact of pivotal

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34:24

Sean Smith on empowering your people to establish...

Let"s Talk Quality ·

2024/11/13

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 opportunities that come with it. He emphasizes the importance of being willing to challenge the status quo, having an openness to learning, and practicing empathy as a quality leader. Smith also discusses the need for quality to be seen as an asset and the importance of building empowered and diverse teams. He encourages

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36:48

Andrea Goddard on her journey from 'the graveyard...

Let"s Talk Quality ·

2024/11/06

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 biotech manufacturing and transitioned into quality after a conversation with her boss! Andrea emphasizes the importance of building strong relationships between quality and other departments within an organization. She discusses the challenges and rewards of working in a global role, including managing different time zones

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42:23

Gary Barrera on why quality leaders should "walk a...

Let"s Talk Quality ·

2024/10/31

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 well as his curiosity about how things work, led him to pursue a career in science. He started in manufacturing and eventually moved into quality, where he discovered his passion for ensuring the reliability and safety of products. We talk about the benefits of gaining exposure to different areas of an organization and how that

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41:10

Andrew Cieri on adapting to change and creating a...

Let"s Talk Quality ·

2024/10/23

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 after the acquisition of the pipeline and commercialisation rights to 2seventy products and Andrew has been tasked with launching this unit! I wanted to talk with Andrew to learn about his journey and how he's gone developing himself - both as a quality professional and leader.Chapters00:00 Introduction and Background03:58 Early

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30:51

Laura Malagon on going from washing glassware in...

Let"s Talk Quality ·

2024/10/10

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 relocated from Miami to Michigan to lead the quality organisation at GRAM. She's had a fantastic journey in quality, starting her career washing glass-wear in a laboratory! We talk about the following:Relocating from Miami to Michigan this year for a new VP role.Laurie's journey into science and quality. Working with different

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30:35

James Myers on how to become a true GxP quality leader.

Let"s Talk Quality ·

2024/10/02

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 transitioned into all encompassing GxP position. As a result James has gained exposure across GCP and GMP and developed himself as a true GxP quality professional. We discuss the following:Transitioning from GCP to GMP.Industry Trends.Gaining GMP Experience.Advancing to VP from director.Building a Team and Pilot

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46:09

Kelly O'Hare on defining and articulating quality to...

Let"s Talk Quality ·

2024/09/25

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 cancer.Kelly shares her journey in quality, discussing her transition from a technical writer to a quality leader. We talk about the importance of quality leaders being able to articulate the value of quality to their organizations. Her insights provide valuable lessons for aspiring quality professionals and

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46:09

Markus Gruell on building and overseeing the Autolus...

Let"s Talk Quality ·

2024/09/18

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.Marcus, shares his journey in the industry and his role as VP of Quality at Autolus. We talk about his transition into the cell and gene therapy field and the challenges and opportunities it presents and move into his experience at Autolus, where he started as an associate director and worked his way up to SVP of Quality. Markus

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36:18

Sonia Razzetti on how to find your voice and...

Let"s Talk Quality ·

2024/09/11

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 in quality and discusses the challenges she faced, including finding her voice in leadership meetings and aligning quality objectives with business priorities. Sonia is really open about the failures she has had to overcome which have helped her develop her career and others. TakeawaysFinding your voice in leadership meetings

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37:15

Irving Ford on leading Adaptimmune through FDA...

Let"s Talk Quality ·

2024/09/04

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 AdaptimmuneTherapeutics. Irving has been through the commercialisation of four cell therapy products, most recently leading Adaptimmune through the BLA and FDA approval of their engineered T cell for solid tumour, Tecelra. Irving talks about his journey from starting out his career as a Microbiologist before making his transition into the pharmaceutical industry. He started

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59 results

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