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Let's Talk QualityAuthor: Hemish Ilangaratne
Lets 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 lets embark on this exciting quality-driven adventure together. Language: en Genres: Business, Careers, Life Sciences, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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From Construction Site to BLA Approval with Andrew Jones
Episode 13
Wednesday, 12 November, 2025
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!
