GLP/GCLP Vendor Oversight and QA Lead (EU)

The Vendor/Supplier QA Auditor role will support the quality oversight of external partners supporting R&D and regulated activities (e.g., CROs, CMOs, laboratories, technology vendors). Lead the end-to-end vendor lifecycle—due diligence, qualification, quality agreements, risk based monitoring, issue management, and continuous improvement—ensuring adherence to GLP/GCP/GMP/GVP, data integrity and applicable regulations. This role partners closely with Clinical, Nonclinical, CMC, Safety, Procurement, Legal, and IT to enable compliant, reliable delivery from third parties.

Main Responsibilities and Accountabilities:

• Vendor Lifecycle & Governance
  • Provide input to R&D/Technical customers on risk-based vendor qualification and requalification strategies (paper assessments, remote/onsite diligence assessments, performance reviews).
  • In collaboration with R&D/Technical/Legal and QA Functional teams contribute to drafting, negotiating, and maintain Quality Agreements aligned to master service agreements (roles/responsibilities, quality standards, change control, deviation management, data integrity, and inspection support).
  • Maintain vendor KPIs/SLAs, quality dashboards, and governance forums for performance, risk, and remediation tracking.
  • Prepare periodic vendor reviews (e.g., QBRs) as appropriate, ensuring KPIs achieve target level, actions, and corrective and preventive actions (CAPAs) are implemented/verified to assess the overall health of the relationship.
• Inspections
  • Support planning of routine GxP audits of CROs, CMOs, labs, and system/service providers; ensuring findings are classified, graded, and reported internally and externally.
  • Liaise with Vendors/Suppliers to assure corrective and preventative CAPA’s are defined and fit-for-purpose. Perform follow up effectiveness checks.
  • Support inspection readiness and provide front/backroom support when third party services are in scope, support development of storyboards.
  • Maintain auditee scheduling, auditor qualification, and audit program metrics.
• Quality Systems & Compliance
  • Ensure vendor practices meet GLP/GCP/GMP/GVP, ICH, OECD, ISO, and data integrity principles (ALCOA+) as well as other function specific guidelines, regulations, standards.
  • Provide input to deviation, complaint, change control, and CAPA processes involving third parties; participate in root cause analysis where appropriate.
  • Contribute to the Quality Management System (QMS)—procedures, templates, and training—for third party oversight.
• Risk Management & Continuous Improvement
  • Maintain risk logs and assessments (e.g., risk registers, FMEA) to prioritize controls and monitoring frequency for specific vendors/suppliers.
  • Drive quality improvements with vendors (process robustness, right first time (cycle time reduction, etc.).
  • Analyze trends (audit findings, deviations, complaints) and present management reviews with actionable insights.
• Cross Functional Partnership
  • Collaborate with Clinical Operations, Nonclinical, CMC, Safety, Supply Chain, Procurement, Legal, and IT to embed quality requirements in scopes of work and contracts.
  • Provide guidance during technology transfers, method validations, sample handling, and data flows between sponsor and vendors.
  • Act as CSL Person-in-Plant as appropriate to provide contemporaneous quality support to CSL specific vendor operations.
  • Train internal stakeholders on third party quality expectations and best practices.
• Maintain and share knowledge of Regulations and Requirements
  • Stay current and up to date with GxP regulations and requirements related to audit management as well as industry/regulatory trends in this area.
  • Identify and/or create new requirements to ensure a high level of quality and communicate internally.

Position Qualifications and Experience Requirements:

• Education
  • Bachelor’s degree in relevant scientific discipline.
• Experience
  • 3+ years of GxP quality experience with direct vendor/CRO/CMO oversight and/or auditing (GLP/GCP/GMP).
  • Demonstrated knowledge of one or more of the following 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.
• 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.