GLP Vendor Oversight and Quality Assurance Lead

Vendor Lifecycle and Governance

Own quality oversight of external partners supporting nonclinical and GLP activities (CROs, laboratories, test facilities).

• Run risk-based qualification and requalification
• Draft and maintain Quality Agreements
• Set vendor KPIs and governance forums
• Ensure actions and CAPAs are closed

Inspections

Identify and prioritize vendors for audit on a risk basis; planning, conducting and grading sits with the audit function.

• Confirm vendor CAPAs are fit for purpose
• 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
• Guide technology transfers and data flows
• Train internal stakeholders

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

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

• 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.