GLP/GCLP Vendor Oversight and QA Lead (EU)

CSL Plasma Inc.; Maidenhead; Hybrid; GBP 60,000 - 90,000; Full time

Job summary

CSL Plasma Inc. is seeking a GLP Vendor Oversight and QA Lead to safeguard nonclinical data integrity across external laboratories and CROs.

You will be the internal authority on GLP, GCP, GMP, and data integrity, leading vendor qualification, quality agreements, risk-based monitoring, and CAPA processes. You will collaborate with Nonclinical Development, Procurement, Legal and IT to embed quality requirements in scopes of work, manage audits and inspections, and drive continuous improvement

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• 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+).
• Strong communication and negotiation skills.

Responsibilities

• Own quality oversight of external partners supporting nonclinical and GLP activities (CROs, laboratories, test facilities).
• Lead the vendor lifecycle: due diligence, qualification, quality agreements, risk-based monitoring, issue management and CAPA closure.
• Identify and prioritise vendors for audit; plan, conduct and grade inspections; verify CAPA effectiveness.
• Embed quality requirements in scopes of work and contracts; guide technology transfers and data flows.
• Embed quality requirements in scopes of work and contracts; train stakeholders.
• Stay current with GLP and GxP regulations and CSL requirements.

Skills

Vendor oversight

GxP quality

Auditing

Regulatory knowledge

Communication

Problem solving

Education

Bachelor's degree in a relevant scientific discipline

Tools

QMS software

Job description

**GLP Vendor Oversight and QA Lead**The integrity of nonclinical data depends on more than what happens inside a company's walls. Much of the critical work in GLP-regulated research — safety studies, toxicology, analytical testing — is carried out by external laboratories and CROs. When that network of partners operates to the highest quality standards, the science is sound. When it doesn't, the consequences reach all the way to patients.This role exists to make sure it works.**Why this role matters**GLP vendor oversight is often invisible when it's done well — and very visible when it isn't. As the internal authority on GLP and nonclinical vendor quality, you will be the person others turn to when the questions are difficult. If you take data integrity seriously, understand the regulatory landscape deeply, and want to shape how a global company manages its external nonclinical network, this is a role with real scope to make a difference.**About the role**Own quality oversight of external partners supporting nonclinical and GLP activities (CROs, laboratories, test facilities). Lead the vendor lifecycle: due diligence, qualification, quality agreements, risk-based monitoring, issue management and continuous improvement, ensuring adherence to GLP/GCP/GMP, data integrity and applicable regulations. Partner with Nonclinical Development, Procurement, Legal and IT.* **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.**Position Qualifications and Experience Requirements:****Education:** Bachelor's degree in a relevant scientific discipline.**Experience**: 3+ years of GxP quality experience with direct vendor/CRO oversight and/or auditing (GLP/GCP/GMP), nonclinical/GLP preferred. Knowledge of OECD GLP, 21 CFR Part 58, Annex 11/Part 11 and data integrity (ALCOA+). Strong communication and negotiation skills.**Competencies**: Works with limited supervision across multinational teams. Strong analytical, problem-solving, influencing and organisational skills. Knowledge of QMS implementation, regulatory frameworks and audit/inspection management.