We are looking for an experienced QPI Expert – Audit Management Lead to drive audit strategy, ensure regulatory compliance, and strengthen our Quality Management System across internal operations and vendor networks. This is a visible, vendor and client-facing role.

Key Responsibilities

  • Define and implement the annual internal and vendor audit strategy
  • Lead internal, vendor, and client audits; manage findings and CAPAs
  • Act as key contact for client auditors and health authority inspections
  • Develop, maintain, and continuously improve the QMS (including ISO 9001 alignment)
  • Oversee SOPs, controlled documentation, and quality tracking systems
  • Drive process improvements and ensure compliance with ICH, GCP, GVP, and local regulations
  • Manage vendor quality oversight and risk-based audit programs
  • Lead and mentor a small team (1–3 members) and collaborate cross-functionally

Profile

  • 8+ years of experience in Quality within the pharmaceutical industry
  • Strong exposure to Pharmacovigilance (PV)
  • Qualified GVP Auditor with solid QMS expertise
  • Good understanding of regulatory frameworks (ICH, GCP, ISO standards)
  • Fluent in English; French (preferred)
  • Strong stakeholder management and client-facing skills

QPI Expert – Audit Management Lead

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