GLP Vendor Quality Lead — External Labs & CROs

CSL; Maidenhead; On-site; GBP 70,000 - 90,000; Full time

Job summary

CSL Maidenhead seeks an experienced GLP Vendor Oversight and QA Lead to ensure external partners meet GLP, GCP and GMP standards. You will oversee the vendor lifecycle, manage audits, and drive CAPAs while aligning with procurement, legal and IT teams.

The role requires a Bachelor’s in a scientific field and 3+ years of GxP/vendor oversight experience. Strong communication and regulatory knowledge are essential for global consistency.

Qualifications

• Bachelor's degree in a relevant scientific discipline is required.
• 3+ years of GxP quality experience with direct vendor/CRO oversight and/or auditing.
• Knowledge of OECD GLP, 21 CFR Part 58, Annex 11/Part 11 and data integrity (ALCOA+).

Responsibilities

• Own quality oversight of external partners supporting nonclinical activities (CROs, laboratories, test facilities).
• Lead the vendor lifecycle: due diligence, qualification, quality agreements, risk-based monitoring, CAPA.
• Coordinate inspections, prepare readiness, and support audit activities.
• Ensure GLP/GCP/GMP, data integrity and regulatory alignment across vendors.
• Embed quality requirements in scopes of work and contracts with cross-functional teams.
• Maintain CSL requirements by tracking regulatory changes in GLP and GxP.
• Provide leadership in risk assessments and continuous improvement for vendor performance.

Skills

Quality oversight

Vendor management

Regulatory knowledge

Communication & negotiation

Education

Bachelor's degree in a relevant scientific discipline

Job description

CSL Maidenhead seeks an experienced GLP Vendor Oversight and QA Lead to ensure external partners meet GLP, GCP and GMP standards. You will oversee the vendor lifecycle, manage audits, and drive CAPAs while aligning with procurement, legal and IT teams.

The role requires a Bachelor’s in a scientific field and 3+ years of GxP/vendor oversight experience. Strong communication and regulatory knowledge are essential for global consistency.