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

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

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

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

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

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

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