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!