The Opportunity:
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.
The Role:
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 & Experience:
Bachelor's degree in a relevant scientific discipline.
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+).
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.
Competencies
Ability to work with limited supervision and with multinational teams and external suppliers speaking different languages.
Strong analytical and demonstrated problem solving skills, excellent interpersonal/communication/influencing/negotiation skills, and excellent organizational skills with respect to planning / tracking and timelines.
Demonstrated knowledge of QMS implementation and regulatory frameworks.
A strong understanding of the requirements for Quality Assurance in relevant GxP discipline.
Experience in audit/inspection management and processes.
Travel: This role will include up to 50% travel