GLP/GxP Vendor Quality Lead

CSL; Maidenhead; On-site; GBP 90,000 - 120,000; Full time

Job summary

CSL Seqirus in Maidenhead, UK, is hiring a GLP Vendor Oversight and QA Lead to ensure external labs and CROs meet GLP/GCP/GMP standards and data integrity. You will own quality oversight of nonclinical partners and manage the vendor lifecycle.

You will lead risk-based qualification, plan and conduct audits, manage CAPAs, and embed quality requirements across contracts and tech transfers. A strong regulatory background and excellent negotiation skills are essential.

Qualifications

• 3+ years of GxP quality experience with direct vendor/CRO oversight and/or auditing.
• Knowledge of OECD GLP, 21 CFR Part 58 and data integrity (ALCOA+).
• Strong communication and negotiation skills.

Responsibilities

• Vendor Lifecycle and Governance: Run risk-based qualification and requalification, draft and maintain Quality Agreements, and set vendor KPIs and governance forums, ensuring actions and CAPAs are closed.
• Inspections: Identify and prioritise vendors for audit on a risk basis; planning, conducting and grading sits with the audit function. Confirm vendor CAPAs are fit for purpose and run effectiveness checks. Coordinate inspection readiness and front- and back-room support.
• Quality Systems and Compliance: Ensure vendor practices meet GLP/GCP/GMP, OECD GLP, 21 CFR Part 58, ICH, ISO and data integrity (ALCOA+). Provide input on third-party deviations, change control, CAPA, and the QMS.
• Risk Management and Continuous Improvement: Lead vendor risk assessments (risk registers, FMEA) to set oversight frequency, improve vendor performance, and present trends at management reviews.
• Cross-Functional Partnership: Embed quality requirements in scopes of work and contracts, guide technology transfers and data flows, and train internal stakeholders.
• Maintain and share knowledge of Regulations and Requirements: Stay current with GLP and GxP regulations and translate changes into CSL requirements.

Skills

GxP quality experience

Vendor/CRO oversight

Auditing GLP/GCP/GMP

Communication skills

Negotiation skills

Regulatory knowledge GLP/GxP

Education

Bachelor’s degree in a relevant scientific discipline

Job description

CSL Seqirus in Maidenhead, UK, is hiring a GLP Vendor Oversight and QA Lead to ensure external labs and CROs meet GLP/GCP/GMP standards and data integrity. You will own quality oversight of nonclinical partners and manage the vendor lifecycle.

You will lead risk-based qualification, plan and conduct audits, manage CAPAs, and embed quality requirements across contracts and tech transfers. A strong regulatory background and excellent negotiation skills are essential.