GXP Audit and Inspection Director

GxP Audit and Inspection Director

Location: CambridgeDepartment: QualityJob 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 execution.
• Provide regular updates to senior leadership on audit outcomes, inspection risks, and compliance trends.
• Maintain metrics and dashboards to monitor audit performance and inspection readiness.
• Build and manage a high‑performing global audit team, including coaching, development, and performance management.
• Collaborate effectively with Quality, Safety, Regulatory Affairs, R&D, Manufacturing and other functions to ensure proactive inspection readiness.
• Act as active member of the Quality Leadership Team and represent the company in regulatory interactions and industry forums.

Qualifications

• Education: Bachelor’s or advanced degree in life sciences, pharmacy, or related field.
• Certifications: Potential QP or QPPV experience.
• Minimum 10 years of experience in GxP auditing and regulatory inspections.
• Proven leadership in matrix‑managing global audit programs.
• Deep understanding of international GxP regulatory requirements and quality systems.
• Experience interacting with regulatory authorities during inspections.
• Strong strategic thinking and risk management skills.
• Excellent communication and stakeholder management.
• Ability to influence across functions and geographies.
• High attention to detail and analytical capability.
• Leadership and team development skills.

Benefits

Opportunities for learning & development through our varied programme. Collaborative, inclusive work environment. Diversity and inclusion.

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