GLP/GCLP Vendor Oversight and QA Lead (EU)

Overview

As a Vendor/Supplier QA Auditor, you ensure external partners meet GLP/GCP/GMP/GVP and data integrity standards. You lead the vendor lifecycle, from qualification to continuous improvement, partnering with Clinical, Nonclinical, CMC, Safety, Procurement, Legal, and IT to enable compliant, reliable third-party delivery. You will shape risk-based qualification strategies, manage audit programs, and drive CAPA and QMS enhancements. This role offers meaningful impact by safeguarding quality across vendor ecosystems and strengthening regulatory readiness. You will work in a cross-functional, collaborative environment with a clear focus on risk control, transparency, and continuous improvement.

Responsibilities

• Vendor Lifecycle & Governance: contribute to risk-based vendor qualification, draft and maintain quality agreements, track KPIs/SLAs and governance forums; prepare periodic vendor reviews with CAPAs.
• Inspections: plan GxP audits of CROs/CMOs/labs, classify findings, liaise on CAPAs, support inspection readiness, maintain audit program metrics.
• Quality Systems & Compliance: ensure GLP/GCP/GMP/GVP and data integrity adherence, participate in deviation/change control/CAPA with third parties, contribute to QMS for third-party oversight.
• Risk Management & Continuous Improvement: maintain risk logs/assessments, drive vendor quality improvements, analyze trends and present actionable insights.
• Cross Functional Partnership: collaborate to embed quality requirements in scopes/contracts, support technology transfers and data flows, train stakeholders.
• Maintain and share knowledge of Regulations and Requirements: stay current with GxP regulations and identify new requirements.

Key requirements

• Bachelor’s degree in a relevant scientific discipline
• 3+ years of GxP quality experience with direct vendor/CRO/CMO oversight and/or auditing (GLP/GCP/GMP)
• Knowledge of ICH (e.g., E6(R2)/E8(R1)/Q9(R1)), OECD GLP, FDA/EMA, EU Annex 11/21 CFR Part 11, and data integrity (ALCOA+)
• Effective communication and negotiation skills
• Ability to work with limited supervision and with multinational teams and external suppliers speaking different languages
• Strong analytical, problem solving, interpersonal/communication/influencing/organizational skills
• Experience in audit/inspection management and processes

• communication
• negotiation
• interpersonal skills
• GxP quality assurance
• GLP/GCP/GMP/GVP compliance
• QMS implementation and maintenance

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