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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.
Job Responsibility
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
Requirements
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