Let's Talk Quality

Hemish Ilangaratne
  • 5.0 (5)
  • LIFE SCIENCES
  • UPDATED WEEKLY

“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 importance of quality and its profound impact on businesses and society. Get ready to engage in insightful discussions, gain valuable perspectives, and unlock the secrets to fostering a culture of quality in every aspect of life. Tune in and let’s embark on this exciting quality-driven adventure together.

  1. Designing Future-Ready Quality Organisations in the Digital Age with Anthony Mire-Sluis

    17H AGO

    Designing Future-Ready Quality Organisations in the Digital Age with Anthony Mire-Sluis

    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 creating systems that let people do their best work. He talks about the following: • How Tony’s science background (immunology, genetics, and a PhD) shaped the way he leads quality • What 10 years in government taught him about great vs poor regulatory filings - and why he moved into industry • The difference between leading a US-centric quality organisation vs a truly global one • Why building a trusted leadership team is the non-negotiable for running global quality at scale • How Tony uses his first 90 days: listening, due diligence, and getting under the skin of the culture • Why he starts transformation from the shop floor - not from the senior leadership layer • Digital and AI in quality: fix the process first, then digitise (otherwise you just create a clunky digital version) • How to reduce firefighting and move quality from reactive to proactive - with better workflows and connected systems • Managing resistance to change and bringing people along early so adoption sticks • Advice for aspiring quality leaders: networking, knowing yourself, and broadening your experience across quality Anthony Mire-Sluis is an authentic, people-first quality leader with a rare blend of regulatory depth and big pharma operational experience - and he’s exactly the kind of leader who makes quality a true enabler of the business. Thank you Tony for sharing your incredible journey. Hope everyone enjoys the show!

    37 min
  2. What 2026 holds for biotech and Quality - with Jon Voss and Ed Armstrong

    FEB 10

    What 2026 holds for biotech and Quality - with Jon Voss and Ed Armstrong

    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 the market feel resilient, and which are still strugglingHow FDA leadership changes are (and aren’t) showing up in day-to-day workThe shift toward written-only FDA interactions and what that means for sponsor–agency relationshipsWhether regulators are prioritising speed or risk, and how that tension plays outWhere AI and digital tools are genuinely adding value today, versus where there’s still a lot of noiseHow Quality has evolved from “policing” to partnership over the last 20 yearsWhy pragmatic, phase-appropriate Quality systems matter more than perfectionBurnout in senior Quality leaders and the risk of doing too much with too few peopleWhat separates Quality leaders who are listened to from those who are merely toleratedWhat the strongest Quality teams will be doing differently by the end of 2026 Ed and Jon bring a huge amount of perspective, humility, and real-world insight to this discussion. This is a conversation for anyone leading Quality through uncertainty and trying to balance patient safety, speed, and sustainability. Hope everyone enjoys the show!

    42 min
  3. Going from ‘In the Weeds’ to the Boardroom: Tactical to Strategic Quality with Elisabeth Hutchins.

    12/10/2025

    Going from ‘In the Weeds’ to the Boardroom: Tactical to Strategic Quality with Elisabeth Hutchins.

    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 that shape strong future QA leadersHow to balance urgent deliverables with long-term quality strategyWhy confidence is essential before others trust you as a strategic partner Elisabeth brings an honest and practical perspective that will resonate with managers and directors looking to step into bigger leadership roles. A highly insightful discussion for anyone looking to evolve into a strategic quality leader.

    35 min
  4. How to win hearts and minds as a quality leader, with Ashley Preston.

    12/03/2025

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

    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 shares: Why he moved from Regulatory into Quality leadershipHow to build trust quickly when you’re new to QAHow leaders can empower technical experts and still influence effectivelyPractical ways to build quality systems and culture in a small biotechWhy communication, self-awareness and soft skills matter more than everHow quality can earn a stronger, more strategic voice at the executive table Ashley’s perspective is grounded, pragmatic, and incredibly relevant for leaders in emerging and clinical-stage biotech. #QualityLeadership #Biotech #RegulatoryAffairs #QualityCulture #LetsTalkQuality

    42 min
  5. Scaling Quality in Radiopharma – with Kyle Powell.

    11/26/2025

    Scaling Quality in Radiopharma – with Kyle Powell.

    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 ft Greenfield site in Salt Lake City.  He talks about the following: How Kyle transitioned from regulatory strategy into quality leadershipWhat it takes to scale a quality system in radiopharma from zero to commercial readinessMoving from tactical work to strategic thinking as a leaderBuilding credibility and influence as a young quality leaderThe importance of empathy and communication in leading teamsHow to justify resources and headcount in a startup environmentCreating a digital-first, paperless quality function from day oneLessons from managing culture and mindset through growthThe softer skills that separate effective leaders from technical expertsAdvice for early-career professionals aiming to step into leadership roles Kyle is an ambitious and thoughtful leader - pragmatic, forward-thinking, and people-first. Thank you, Kyle, for sharing your incredible journey. Hope everyone enjoys the show!

    30 min
  6. From Construction Site to BLA Approval with Andrew Jones

    11/12/2025

    From Construction Site to BLA Approval with Andrew Jones

    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 first, build trust, don’t lie in front of an inspector - and he’s done this in high-pressure, time-sensitive environments where approval is the company’s lifeline.

 He talks about the following:
 • Moving from validation into site QA at a CDMO and how that set the foundation for future inspection work. • Lessons from Andrew’s early BLA work at J&J and negotiating specs with R&D and FDA. • The reality of building a cell therapy facility during the pandemic and getting it inspection ready. • Why small and mid-sized biotechs underestimate the time vs patience problem in inspection readiness. • How to break inspection readiness into risk-based subcomponents instead of ‘boiling the ocean’. • The core inspection principles Andrew teaches his teams (listen first, build trust, never lie). • How to train a team that has never sat in front of an FDA investigator before. • The mindset shift from clinical to commercial in cell therapy – and why turnaround time becomes everything. • Leading at a steady temperature through BLA, inspections and approval. • Creating a culture where people feel safe to speak up, challenge and improve systems. Andrew is a calm, values-led quality leader who knows how to get therapies over the line without losing the team in the process.

 Thank you Andrew for sharing your incredible journey.

 Hope everyone enjoys the show!

    33 min
  7. The First 90 Days of Building Quality in a Startup with Theresa Donegan

    11/05/2025

    The First 90 Days of Building Quality in a Startup with Theresa Donegan

    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 large and small companies, CROs, and now Climb Bio. Her path is a masterclass in adaptability, and in today’s startup environment, her insights couldn’t be more relevant. She talks about the following: • How Theresa’s career evolved from QC lab work to VP of Quality leadership • The mindset shift from big pharma to biotech startups • What the first 30/60/90 days look like when you’re building quality from scratch • How to balance pragmatism, speed, and compliance in early-stage biotech • How to use consultants effectively • The right time to bring in permanent quality leadership  • What “good” looks like in an early-stage quality system • How to align leadership teams and departments when everything is moving fast • How to spot red and green flags when joining a startup • The key soft skills quality professionals must build early in their careers • How to prioritise your first three hires when you finally have budget Theresa is an incredibly grounded and thoughtful leader, combining technical depth with an empathetic leadership style that every quality professional can learn from. Thank you Theresa for sharing your incredible journey. Hope everyone enjoys the show!

    38 min
  8. Why the Best Quality Leaders Walk the Floor, with Iain Rusling.

    10/29/2025

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

    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 advantage. Iain began in QC at small biotechs, built facilities and quality systems, moved through technology transfer and inspections, and later led global/EMEA functions from Munich.  Along the way he faced setbacks, loss, consulting chapters, and major inflection points - all of which shaped a people‑centered leadership style that keeps him on the shop floor, not behind a desk. He talks about the following: Starting in QC on £9,000 a year and the mindset that accelerated his careerBuilding an oligonucleotide facility from scratch and what it taught him about influence without authorityMoving from site roles to global, matrixed leadership - how to earn trust across borders and culturesInspections and licenses (FDA/MHRA) as leadership pressure testsWhy quality must be represented in the boardroom - and how to make the caseTurning ‘quality as a cost’ into ‘quality as continuity of revenue’Practical ways quality leaders can humanise their function: walk the floors, speak operations, build relationshipsInterview advice for QA leaders: questions to uncover culture, investment and phase‑appropriate systemsClinical → Commercial transitions: where companies get stuck and how advisory/fractional quality leaders helpAI realism: useful for trends and signals, but it can’t replace human judgment on the shop floor Iain is a thoughtful, pragmatic leader who combines technical depth with empathy, candour and a relentless focus on relationships. Thank you Iain for sharing your incredible journey. Hope everyone enjoys the show!

    40 min
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Ratings & Reviews

5
out of 5
5 Ratings

About

“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 importance of quality and its profound impact on businesses and society. Get ready to engage in insightful discussions, gain valuable perspectives, and unlock the secrets to fostering a culture of quality in every aspect of life. Tune in and let’s embark on this exciting quality-driven adventure together.

Information

  • Creator
    Hemish Ilangaratne
  • Years Active
    2023 - 2026
  • Episodes
    61
  • Rating
    Clean
  • Copyright
    © Copyright 2026 Hemish Ilangaratne
  • Show Website
    Let's Talk Quality

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