GCP Quality Assurance Expert

Job title: GCP Quality Assurance Expert

Job type: Full-time, permanent position

Location: West London, UK – hybrid/remote (with monthly travel)

Remuneration: Competitive salary and benefits package

Cpl Life Sciences is partnering with an innovative and growing cutting-edge biotech currently operating in stealth mode. We are seeking an experienced GCP Quality Assurance Expert to become the first permanent QA hire within a growing clinical-stage biotechnology company. The business is at the heart of Neurology and CNS development, encompassing both AI technology and traditional drug development.

This is a unique opportunity to build and own the Quality function from the ground up, creating a scalable GCP-focused QMS and establishing the quality foundations that will support programmes from early clinical development through to pivotal Phase III studies. Acting as the company's quality expert, you will lead sponsor-side GCP activities, oversee CROs and external partners, manage audits and inspection readiness, and drive a culture of quality across the organisation. This role offers significant autonomy, visibility and influence, with the opportunity to shape both quality strategy and future team growth.

Key Responsibilities

• Establish and maintain a fit-for-purpose GCP Quality Management System (QMS).
• Lead sponsor-side GCP quality oversight across CROs, vendors and investigator sites.
• Develop and manage SOPs, CAPAs, deviations, inspections and audit programmes.
• Support clinical development activities from early-phase studies through pivotal Phase III trials.
• Drive inspection readiness and partner with Regulatory and Clinical teams on compliance strategy.
• Serve as the primary quality representative within a lean and highly collaborative environment.

Essential Experience

• Significant QA experience within biotech, pharmaceutical or advanced therapy environments. (10+ years ideally)
• Strong expertise in GCP and sponsor oversight.
• Proven experience building or enhancing Quality Management Systems.
• Experience supporting early-stage and/or Phase III clinical trials.
• Demonstrated success managing outsourced development models and external vendors.
• Excellent knowledge of FDA, EMA, MHRA and ICH-GCP requirements.

Highly Desirable

• Cell & Gene Therapy, AAV or ATMP experience.
• Neurology or rare disease programme experience.
• Experience as a standalone QA lead or first QA hire.
• Regulatory inspection and audit leadership experience.
• Knowledge of GMP-GCP interfaces and advanced therapy development.

This role requires an expert in GCP having ideally started their career in GCP and development within this area in QA.

For more information, please reach out to lucy.kirkaldy@cpl.com