Quality Assurance Leader - GCP and AAV Development

Job Title: Quality Assurance Leader – AAV development

Job Type: Full time, permanent role

Job Location: West London, UK (Hybrid)

Remuneration: Competitive salary and package

Stealth Mode Biotechnology Company, AAV Gene Therapy | Clinical Stage Assets

Cpl Life Sciences is partnering with a highly innovative, well-funded biotechnology company operating in stealth mode. The business is developing a pipeline of next-generation AAV-based therapies and is entering a pivotal period of growth as it advances programmes towards the clinic.

We are seeking an experienced and hands‑on Quality Leader to become the company’s first dedicated Quality hire. This is a rare opportunity to build and shape the Quality function from the ground up, establishing the quality culture, systems, processes, and governance that will support the development and delivery of transformative gene therapies.

You will act as the quality representative across clinical development, regulatory affairs, CMC, external manufacturing partners, and strategic vendors. You will be responsible for establishing GCP standards and quality frameworks across the business whilst providing oversight of all quality‑related activities associated with clinical trial applications (CTAs), clinical operations, and AAV development programmes.

This role requires someone who enjoys building rather than maintaining, can operate in a fast‑moving environment, and is comfortable working autonomously whilst influencing senior stakeholders across the organisation.

• Establish and lead the company’s Quality function as the first dedicated QA professional.
• Develop and implement a scalable quality strategy aligned to the company’s growth plans and clinical ambitions.
• Build quality systems, policies, SOPs, governance structures, and quality culture across the organisation.
• Act as the subject matter expert for GxP compliance and quality‑related decision making.
• Partner with executive leadership to ensure quality is embedded across all functions.

• Develop and maintain the sponsor‑side GCP Quality Management System.
• Establish quality standards, procedures, and oversight models to support global clinical studies.
• Provide quality leadership throughout CTA preparation, submission, approval, and execution activities.
• Ensure inspection readiness and ongoing compliance across all clinical programmes.
• Oversee CROs, clinical vendors, laboratories, and trial sites through risk‑based quality management approaches.
• Lead quality event management including deviations, CAPAs, investigations, root cause analysis, and continuous improvement activities.
• Support audit planning, execution, and follow‑up activities.

• Provide QA review and oversight of CTA documentation and supporting submissions.
• Collaborate closely with Regulatory Affairs to ensure compliance with applicable global regulations and quality expectations.
• Support interactions with regulatory authorities and inspection activities.
• Ensure quality considerations are integrated into development plans and regulatory strategies.

• Provide quality oversight of CDMOs and manufacturing partners supporting AAV development and production.
• Support qualification, auditing, and ongoing management of external partners.
• Ensure robust oversight of GMP activities supporting clinical development.
• Manage the GMP‑GCP interface, including product traceability, handling, storage, distribution, and accountability.
• Support quality review of manufacturing changes, investigations, deviations, and supplier quality activities.

• Build, implement, and maintain fit‑for‑purpose quality systems.
• Develop quality metrics, KPIs, and…