At a Glance
- Tasks: Oversee quality of external partners in nonclinical and GLP activities, ensuring compliance and data integrity.
- Company: Join a global leader in biopharmaceuticals committed to patient safety and quality.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic role with cross-functional collaboration and career advancement opportunities.
- Why this job: Make a real impact on patient safety by ensuring high standards in research quality.
- Qualifications: Bachelor’s degree in science and 3+ years of GxP quality experience required.
The predicted salary is between 60000 - 80000 £ per year.
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.
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.
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit CSL accessibility statement.
GLP/GCLP Vendor Oversight and QA Lead (EU) in Maidenhead employer: CSL
As an Associate Director in Procurement Enablement at CSL, you will be part of a forward-thinking organisation that prioritises sustainability and governance while fostering a culture of continuous improvement and talent development. With a commitment to employee growth through the Global Procurement Academy and a collaborative work environment, CSL offers a unique opportunity to influence procurement practices on a global scale, making it an excellent employer for those seeking meaningful and impactful careers.
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