QA/GxP Lead

Job Title: QA/GxP Lead

Job Type: Full-time, permanent

Location: London, UK - Hybrid

Remuneration: Up to £90,000

Cpl Life Sciences is partnering with an innovative biotech company to appoint a QA/GxP Lead to support a late-stage clinical development programme.

This is an excellent opportunity for an experienced quality professional to take ownership of sponsor-side quality activities, ensuring compliance across GCP and GMP operations while supporting a complex and highly regulated clinical programme. The role offers significant visibility, autonomy, and the opportunity to shape quality systems within a growing organisation.

Key Responsibilities

Clinical Quality & GCP Oversight

• Lead sponsor-side GCP quality activities for a late-stage clinical programme.
• Implement risk-based oversight of CROs, investigator sites, laboratories, and external vendors.
• Manage quality events, deviations, CAPAs, and inspection readiness activities.
• Support quality governance and vendor oversight processes.

Vendor & Manufacturing Quality

• Provide quality oversight of external manufacturing partners.
• Support quality agreements, change controls, investigations, and supplier management activities.
• Ensure compliant management of investigational products throughout the clinical supply chain.

Computerised Systems & Data Integrity

• Support validation and oversight of GxP-relevant computerised systems.
• Ensure compliance with data integrity requirements and electronic records regulations.
• Contribute to quality risk assessments relating to digital platforms and emerging technologies.

Inspection Readiness & Regulatory Support

• Lead audit and inspection preparation activities.
• Support responses to regulatory inspections and partner audits.
• Contribute to quality aspects of regulatory submissions and health authority interactions.

Requirements

• Degree in Life Sciences, Pharmacy, Quality Assurance, Engineering, or related discipline.
• Extensive experience within GxP Quality Assurance in a biotech, pharmaceutical, CRO, or clinical research environment.
• Strong knowledge of GCP regulations and clinical quality systems.
• Experience overseeing external vendors and service providers.
• Ability to influence stakeholders across a matrix organisation.

Desirable

• Experience supporting Phase III or pivotal clinical studies.
• Audit and regulatory inspection experience.
• GMP and CMC quality exposure.
• Knowledge of CSV, GAMP 5, data integrity, and electronic systems compliance.
• Experience within biologics, advanced therapies, cell therapy, or gene therapy.
• What's on Offer
• Opportunity to shape and enhance quality processes within a growing biotech organisation.
• Significant ownership and autonomy.
• Exposure to innovative clinical development programmes.
• Collaborative, high-performing environment.
• Strong potential for future career growth.

For a confidential discussion or to learn more, please apply or contact me at lucy.kirkaldy@cpl.com