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
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