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QA/GxP Lead
Late-Stage Gene Therapy | AI-Driven Biotech
West London, UK – Hybrid
Competitive salary and package
Cpl Life Sciences is partnering with an innovative AI-driven biotech company to appoint a QA/GxP Lead to support a pivotal late-stage gene therapy programme. This is a unique opportunity to join a growing organisation developing advanced therapies for neurological disease, where quality plays a critical role in programme success. Reporting into senior leadership, you will act as the quality representative across clinical, manufacturing, regulatory, and partner activities, ensuring robust GxP compliance and inspection readiness throughout development.
Key Responsibilities
Quality & GxP Oversight
- Lead and maintain the sponsor-side GCP quality framework for a pivotal Phase III clinical programme.
- Manage quality systems, deviations, CAPAs, quality events, and inspection readiness activities.
- Develop and oversee risk-based quality management processes across CROs, laboratories, clinical sites, and external vendors.
- Ensure quality agreements and oversight plans remain effective and compliant.
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GMP & Manufacturing Quality
- Support quality oversight of external manufacturing partners producing investigational gene therapy products.
- Manage the GMP-GCP interface, including product handling, traceability, storage, shipment, and accountability.
- Support change controls, quality reviews, and manufacturing-related quality activities.
AI & Computerised Systems
- Provide quality oversight for AI-enabled systems used within clinical development.
- Support CSV activities, data integrity requirements, and compliance with applicable GxP regulations.
- Assess risks associated with emerging AI technologies and ensure appropriate governance and documentation.
Regulatory & Inspection Readiness
- Lead preparation for regulatory inspections and audits.
- Support quality input into regulatory submissions and agency interactions.
- Drive continuous improvement initiatives using quality metrics and trending analysis.
Essential
- Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality Assurance, or related discipline.
- 10+ years' experience within GxP Quality Assurance in biotech, pharmaceutical, or CRO environments.
- Strong knowledge of GCP and the GMP-GCP interface for investigational medicinal products.
- Experience overseeing external vendors and partners through quality systems and risk-based oversight.
- Excellent stakeholder management, communication, and problem-solving skills.
- Ability to thrive in a lean, fast-paced, and entrepreneurial environment.
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Desirable
- Experience supporting Phase III or other late-stage clinical programmes.
- Exposure to regulatory inspections, sponsor audits, or vendor audits.
- Knowledge of gene therapy, ATMPs, or advanced biologics.
- Experience with CSV, GAMP 5, 21 CFR Part 11, and data integrity requirements.
- Understanding of AI governance, quality frameworks, and emerging regulatory expectations.
For more information please contact lucy.kirkaldy@cpl.com
Please note that this is a young company and needs someone who can come into the business and hit the ground running. You must be experienced and be able to work in a face paced and forever changing environment. Someone in the office on a hybrid basis is preferred.
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