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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

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,

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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

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31:50

Problem Solving, Partnerships, and Putting Yourself...

Let"s Talk Quality ·

2026/03/03

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. Yes, she has held senior quality roles across innovator companies, CDMOs, and now one of the largest CROs

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33:04

Overcoming Self-Doubt in Quality Leadership, with...

Let"s Talk Quality ·

2026/02/24

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 teams. But what makes her story powerful is how openly she connects her personal journey to the leader she

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37:22

Designing Future-Ready Quality Organisations in the...

Let"s Talk Quality ·

2026/02/17

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 leadership is less about having all the answers, and more about building trust, listening properly, and

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41:46

What 2026 holds for biotech and Quality - with Jon...

Let"s Talk Quality ·

2026/02/10

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 current state of pharma and biotech, and whether the market has really bottomed outWhich modalities and parts of

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34:43

Going from ‘In the Weeds’ to the Boardroom: Tactical...

Let"s Talk Quality ·

2025/12/10

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 3The moment she realised she needed to stop firefighting and start planningHow she built the quality team around her to enable strategic thinkingThe soft skills

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42:23

How to win hearts and minds as a quality leader, with...

Let"s Talk Quality ·

2025/12/03

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 something far more important than technical depth: communication, trust, and people.In the episode, Ashley

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30:12

Scaling Quality in Radiopharma – with Kyle Powell.

Let"s Talk Quality ·

2025/11/26

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 radiopharmaceuticals, helping to stand up new facilities, and now leading the full quality build-out for Ratio’s 65,000 sq

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33:00

From Construction Site to BLA Approval with Andrew Jones

Let"s Talk Quality ·

2025/11/12

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 biopharma, biotech, cell and gene and commercial launches. He’s very intentional about principles - listen

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38:26

The First 90 Days of Building Quality in a Startup...

Let"s Talk Quality ·

2025/11/05

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 compliance and patient safety.Theresa’s career began in the QC lab before moving through GLP, GCP, and GMP roles in

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40:28

Why the Best Quality Leaders Walk the Floor, with...

Let"s Talk Quality ·

2025/10/29

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 mindset, communication, and cross‑functional collaboration required to turn quality into a competitive

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45:58

Why AI Won’t Take Your Job - But Someone Using AI...

Let"s Talk Quality ·

2025/10/15

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 compliance at a tech-driven CRO, where speed and automation are core to the model.Subbu’s journey spans shop

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38:50

Building phase-appropriate quality systems early, and...

Let"s Talk Quality ·

2025/10/08

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 training led her into quality at GE Healthcare and Philips, before moving into biotech with bluebird bio

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48:02

Sep Naraghi on Creating Order from Chaos in Startup...

Let"s Talk Quality ·

2025/10/01

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 under resource constraints.Sep’s journey is anything but linear: from QC in generics to supplier quality at

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57:18

Tony Jones on Achieving Clarity in Quality Leadership

Let"s Talk Quality ·

2025/09/10

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 episode, Hemish was joined by Tony Jones, Vice President, Corporate Quality at Syneos Health.Tony’s path is anything but typical: NHS clinical biochemistry, clinicalpharmacokinetics at Beecham/GSK, a move to France, and then landing, almost by accident, in QA leadership in New Jersey. He went deep on GLP and data principles,

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44:08

Scott Pherson on Building Quality from Day Zero

Let"s Talk Quality ·

2025/08/27

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 three times. And now, he’s building quality from scratch at a company that hasn’t even dosed a patient yet.Scott has nearly 20 years’ experience across QC, operations, and quality leadership, having worked at Biogen, Shire, AvroBio and more. Now, as the first quality hire at AS2 Bio, he’s building systems, shaping culture,

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36:44

Stephanie Martin on Leading When You’re the Youngest...

Let"s Talk Quality ·

2025/08/20

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 traditional. She started out as a nuclear engineer at a shipyard before pivoting into biotech and building a career in quality. What stands out is how she has faced bias around her age and appearance head-on, and still accelerated into leadership roles by focusing on EQ, credibility, and consistent performance.Stephanie's story is a

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46:15

Megan Callan on Leading Quality at Abeona to it’s...

Let"s Talk Quality ·

2025/08/13

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 been a masterclass in building a quality organisation that can handle the demands of commercial manufacturing - all while driving a digital transformation and keeping a patient-first mindset.Megan has a unique career journey, moving across different industries and company sizes, and in this conversation, she opens up about how

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43:08

Nolan Polson on Leading Through Juno, Celgene, BMS...

Let"s Talk Quality ·

2025/08/06

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 he’s one of the few leaders who’s built quality teams at every stage – from biologics at Amgen to radiopharma at Janssen, to launching two first-in-class cell therapies at Juno/Celgene/BMS.Nolan’s career path is a great example of what it looks like to carry foundational quality principles into fast-paced, high-growth settings

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65 results

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