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QA/GxP Lead | Gene Therapy | London (Hybrid, 3 days/week)
We're partnering confidentially with a very well-funded, AI-driven biotechnology company with a gene therapy programme moving into a pivotal Phase III trial. Backed by leading academic and investment partners, this is a mature, well-resourced programme - not an early-stage concept.
They're looking for a hands-on QA/GxP Lead to be the day-to-day quality voice on the programme, owning and evolving a fit-for-purpose GxP quality system from an early stage. This is a genuine individual-contributor role with real scope to shape how quality is done, reporting to the Director of Quality.
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What you'll own:
- Sponsor-side GCP quality system for a Phase III gene therapy trial (ICH E6(R3), 21 CFR Parts 11/50/56/312, EU CTR)
- Risk-based oversight of CROs, investigator sites, and vendors - quality agreements, audits, KQIs/KRIs
- The GMP-GCP interface for the investigational product, working closely with an external manufacturing partner
- Inspection readiness and hosting for FDA, EMA, and MHRA
- Growing oversight of AI-driven trial systems as they're integrated into the programme
What you'll bring:
- 10+ years' GxP quality assurance experience in clinical trials (sponsor, CRO, pharma, or biotech)
- Strong, current knowledge of GCP (ICH E6(R3)) and the GMP-GCP interface for investigational products
- A track record of overseeing external partners through quality agreements and risk-based oversight, rather than direct operational control
- Comfortable operating lean, and confident influencing partners you don't directly manage
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Nice to have: experience leading regulatory inspections; Phase III/pivotal trial exposure; cell & gene therapy/ATMP background; CSV/GAMP 5 or AI risk framework knowledge (EU AI Act, ISO/IEC 42001).
Location: London (Soho), 3 days/week in-office
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