Cpl Life Sciences
Quality Assurance Lead
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Quality Assurance Lead (GxP) - Cell & Gene Therapy
We are seeking an experienced Quality Assurance Lead to provide quality leadership for a late-stage gene therapy programme. This is a hands-on individual contributor role with responsibility across GCP, GMP oversight, vendor management, inspection readiness, and quality systems.
You will act as the key quality representative within a pivotal Phase III clinical programme, ensuring compliance across clinical operations, external partners, and manufacturing activities while helping build and enhance a fit-for-purpose GxP quality framework.
GCP Quality & Clinical Oversight
- Lead sponsor-side GCP quality activities for a Phase III gene therapy programme.
- Manage vendor, CRO, laboratory, and site oversight through risk-based quality management.
- Oversee deviations, CAPAs, audits, inspections, and quality agreements.
- Drive inspection readiness and promote a strong quality culture.
GMP & Manufacturing Oversight
- Act as QA partner to external manufacturing organisations.
- Support GMP compliance, change control, batch disposition, and quality agreements.
- Manage the GMP-GCP interface for investigational products.
- Support quality activities relating to ATMPs, biosafety, and traceability requirements.
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AI & Computerised Systems
- Support oversight of AI-enabled clinical technologies.
- Ensure compliance with CSV, GAMP 5, data integrity, and Part 11 requirements.
- Contribute to AI governance, validation, and risk management activities.
Continuous Improvement
- Monitor quality metrics and supplier performance.
- Drive quality system improvements and training initiatives.
- Support regulatory submissions and health authority interactions.
What You'll Bring
Essential
- Degree in Life Sciences, Pharmacy, Quality, Engineering, or related field.
- 10+ years' experience in GxP Quality Assurance within pharma, biotech, sponsor, or CRO environments.
- Strong knowledge of GCP and the GMP-GCP interface.
- Experience managing external vendors and quality agreements.
- Proven background in deviations, CAPAs, audits, inspections, and quality risk management.
- Ability to influence stakeholders in a fast-paced, growing organisation.
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Desirable
- Phase III or pivotal trial experience.
- Cell & Gene Therapy / ATMP experience.
- GMP or CMC quality oversight experience.
- CSV, GAMP 5, data integrity, and Part 11 knowledge.
- Experience with regulatory inspections and submissions.
- Knowledge of AI governance frameworks and regulatory expectations.
Why Join?
- Play a critical role in a late-stage gene therapy programme.
- Work at the intersection of biotechnology, AI, and clinical development.
- Own and shape quality processes in a growing, innovative organisation.
- Gain exposure to advanced therapies and emerging AI-enabled clinical technologies.
Location
London-based role with close collaboration across clinical, quality, regulatory, and technology teams in a highly innovative and mission-driven environment.
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