QPI Expert – Audit Management Lead

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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