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