GLP Vendor Oversight and Quality Assurance Lead

CSL•King of Prussia, PA

2d•Onsite

About The Position

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.

Requirements

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+).
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.
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.

Responsibilities

Run risk-based qualification and requalification, draft and maintain Quality Agreements, and set vendor KPIs and governance forums, ensuring actions and CAPAs are closed.
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.
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.
Lead vendor risk assessments (risk registers, FMEA) to set oversight frequency, improve vendor performance, and present trends at management reviews.
Embed quality requirements in scopes of work and contracts, guide technology transfers and data flows, and train internal stakeholders.
Stay current with GLP and GxP regulations and translate changes into CSL requirements.