Quality Assurance Lead

• Quality Assurance Lead (Gx P) - 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 Gx P 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.
• 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.
• Monitor quality metrics and supplier performance.
• Drive quality system improvements and training initiatives.
• Support regulatory submissions and health authority interactions.
• What You'll Bring
• Degree in Life Sciences, Pharmacy, Quality, Engineering, or related field.
• 10+ years' experience in Gx P 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.
• 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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