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Cpl Life Sciences
QA/GxP LeadCpl Life Sciences • London Area, United Kingdom, United Kingdom
QA/GxP Lead

QA/GxP Lead

Cpl Life Sciences • London Area, United Kingdom, United Kingdom
20 days ago
Salary
£90,000.00 yearly
Job type
  • Full-time
  • Permanent
Job description

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

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QA/GxP Lead • London Area, United Kingdom, United Kingdom

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