# From Construction Site to BLA Approval with Andrew Jones

Page: https://stenobird.com/podcast/let-s-talk-quality-6567110/from-construction-site-to-bla-approval-with-andrew-jones
Text version: https://stenobird.com/podcast/let-s-talk-quality-6567110/from-construction-site-to-bla-approval-with-andrew-jones.md
Podcast: [Let's Talk Quality](https://stenobird.com/podcast/let-s-talk-quality-6567110)
Published: 2025-11-12T16:00:00+00:00
Episode link: https://rx-group.io/captivate-podcast/from-construction-site-to-bla-approval-with-andrew-jones
Audio file: https://episodes.captivate.fm/episode/407637c2-0c4e-4af0-8ef6-acff69d84604.mp3
Processing state: not_requested
JSON: https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/from-construction-site-to-bla-approval-with-andrew-jones
Duration seconds: 1980

## Resource

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…

## Actions

- request_transcript: `POST https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/from-construction-site-to-bla-approval-with-andrew-jones/transcription-requests` — Idempotently request low-priority transcript generation for this episode.
- read_markdown: `GET https://stenobird.com/podcast/let-s-talk-quality-6567110/from-construction-site-to-bla-approval-with-andrew-jones.md` — Read the agent-friendly Markdown representation of this episode resource.

A page view does not enqueue transcription. Agents should invoke `request_transcript` explicitly when they need this episode processed.

## Transcript

Full transcripts are not published on public pages unless there is a clear rights basis.