GXP Audit and Inspection Director

GxP Audit and Inspection Director

Location: Cambridge
Department: Quality
Job type: Permanent

At Mundipharma, we are proud of the work we do to uphold the highest standards of quality, compliance, and patient safety.

Responsibilities

• Strategic Leadership: Develop and execute a global GxP audit and inspection strategy aligned with company objectives and the Quality Management System.
• Lead cross‑functional inspection readiness programs, including mock inspections.
• Serve as the primary point of contact for regulatory inspections.
• Oversee internal and external audit programs across all GxP areas, including vendor and supplier audits.
• Ensure audit schedules are risk‑based and cover all relevant GxP domains.
• Coordinate pre‑inspection activities such as training, documentation review, and facility walkthroughs.
• Lead inspection response teams and manage post‑inspection responses, remediation, and CAPA ...