x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

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

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

en

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

en

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

en

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

en

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

en

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

en

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,

en

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,

en

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

en

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

en

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

en

54:16

Ashley Argiras on scaling quality in a platform biotech

Let"s Talk Quality ·

2025/07/30

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 like in a tech-enabled, platform biotech - and she’s doing it by shifting how people think, not just how they work.Ashley’s journey into science started in high school - not in a lab, but making ice cream during chemistry class. That moment sparked a lifelong curiosity that took her to Indiana University, and eventually into

en

59:44

Maja Pedersen on AI, Strategic Thinking, and Evolving...

Let"s Talk Quality ·

2025/07/23

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 across six global sites, and has a brilliant perspective on how quality leadership is evolving - especially when it comes to people, systems and technology.She has a calm, clear way of thinking, and we covered everything from shifting your mindset as a leader, to integrating AI in a global quality function, to maintaining

en

39:40

Carolina Valoyes on the guiding principles that have...

Let"s Talk Quality ·

2025/04/16

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, Senior Vice President of Quality and Compliance at BioNova Scientific.I really wanted to speak to Carolina because her story is one of bold decisions, genuine self-awareness, and a leadership style grounded in service, not ego.She started out as an engineer in Colombia, came to the US without speaking a word of English, and

en

43:02

Jose Caraballo on Adaptability, Leadership & the...

Let"s Talk Quality ·

2025/03/19

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 quality leadership.Jose started his career in process engineering, optimizing yields and scaling up production.Over time, he made a deliberate shift into quality leadership, recognizing that understanding the external side of the business - suppliers, regulators, and customers, was just as important as technical expertise.Now,

en

56:54

Andrea Karpinecz on building QC teams to commercial...

Let"s Talk Quality ·

2025/03/12

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, scale teams for commercialization, and thrive in a high-pressure environment.Andrea has been in cell therapy for 16+ years, playing a pivotal role in bringing multiple therapies to market - including some of the first commercially approved CAR-T and TIL therapies. She’s seen firsthand what it takes to move from the bench to

en

50:52

Brian Nunnally returns to the show! How to break...

Let"s Talk Quality ·

2025/03/05

🚀 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 important topics in career growth - mentorship.Brian’s career is a perfect example of how mentorship, strategic career moves, and leadership development can accelerate your path to the top. He shares his journey from QC scientist to leading an entire global Quality Control organization, and why having the right mentors at the

en

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

en

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

en

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

en

56 results

Similar Podcasts

Classic Radio Science Fiction

solgoodmedia.com

Mission to Mars

Inception Point Ai

The 365 Days of Astronomy

365DaysOfAstronomy.org

Creek Devil

william Jevning

UFO Chronicles Podcast

Nik Hunter