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 3
• The moment she realised she needed to stop firefighting and start planning
• How she built the quality team around her to enable strategic thinking
• The soft skills that shape strong future QA leaders
• How to balance urgent deliverables with long-term quality strategy
• Why 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.

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 leadership
• How to build trust quickly when you’re new to QA
• How leaders can empower technical experts and still influence effectively
• Practical ways to build quality systems and culture in a small biotech
• Why communication, self-awareness and soft skills matter more than ever
• How 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

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 leadership
• What it takes to scale a quality system in radiopharma from zero to commercial readiness
• Moving from tactical work to strategic thinking as a leader
• Building credibility and influence as a young quality leader
• The importance of empathy and communication in leading teams
• How to justify resources and headcount in a startup environment
• Creating a digital-first, paperless quality function from day one
• Lessons from managing culture and mindset through growth
• The softer skills that separate effective leaders from technical experts
• Advice 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!

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!

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!

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 career
• Building an oligonucleotide facility from scratch and what it taught him about influence without authority
• Moving from site roles to global, matrixed leadership - how to earn trust across borders and cultures
• Inspections and licenses (FDA/MHRA) as leadership pressure tests
• Why quality must be represented in the boardroom - and how to make the case
• Turning ‘quality as a cost’ into ‘quality as continuity of revenue’
• Practical ways quality leaders can humanise their function: walk the floors, speak operations, build relationships
• Interview advice for QA leaders: questions to uncover culture, investment and phase‑appropriate systems
• Clinical → Commercial transitions: where companies get stuck and how advisory/fractional quality leaders help
• AI 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!

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 floor experience, software development, cloud QMS implementation, startup failures, AI audit tools, and now redefining what a modern bioanalytical CRO can be.

He talks about the following:

• What quality looks like when you build a company from scratch with AI and automation at the core.

• How to move fast without breaking compliance.

• What GLP and GCP readiness really involves in a fast-paced environment.

• How to use LLMs and automation to handle audit questionnaires and generate CAPAs.

• Why most GenAI pilots are failing in biotech.

• How to think clearly about the noise vs. signal when it comes to AI tools.

• Why quality leaders need to be AI-literate to stay relevant.

• The slow death of traditional entry-level QA jobs – and what might replace them.

• Why AI won’t take your job – but someone using AI better than you will.

• What a good quality mindset looks like in the age of digital transformation

Subbu is a brilliant thinker who brings clarity, experience, and grounded insight to an often confusing topic.

Thank you Subbu for sharing your incredible journey.

Hope everyone enjoys the show!

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 during rapid growth. She’s since led in several startups and now at Monte Rosa, where she’s implemented validated systems early and embedded a genuine culture of quality across GxP.

She talks about the following:

• Why a non-traditional path (business → supply chain → Six Sigma) can be a superpower in Quality.
• From paper to validated eQMS: how bluebird bio migrated training & documents and why they verified 100% of records.
• Trigger points for moving beyond paper: signs you’re outgrowing a doc control room and how to stand up DMS/LMS/LIMS early.
• Phase-appropriate, risk-based thinking: using data, science and regulations - without becoming a blocker.
• Making quality ‘cool’: education, storytelling, and visible sponsorship from ELT.
• Leading without fear: replacing “inspection readiness day” with “inspection readiness every day.”
• Critical thinking over checkbox compliance: hiring, interview questions, and building the muscle across teams.
• Working with functional heads: cadence of 1:1s, being a partner (not a gate), and influencing through solutions.
• Roadmaps that breathe: Karin’s 3‑year plan, quarterly outcomes, and how transparency sustains engagement in uncertainty.
• AI pragmatism in quality: where note-taking and drafting help now - and where human judgment still rules.

Karin is a thoughtful, pragmatic Quality leader who balances compliance with business value - bringing people with her as she builds systems that last.

Thank you Karin for sharing your incredible journey.

Hope everyone enjoys the show!