Episode
From Construction Site to BLA Approval with Andrew Jones
- Podcast
- Let's Talk Quality
- Published
- Nov 12, 2025
- Duration seconds
- 1980
- Processing state
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Summary
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 f…