GXP Audit and Inspection Director

GxP Audit and Inspection Director

Location: Cambridge

Department: Quality

Job type: Permanent

Join us and make a difference when it matters most! At Mundipharma, we are proud of the work we do to uphold the highest standards of quality, compliance, and patient safety. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.

The Team. The role will strategically lead and coordinate the global GxP audit and inspection readiness program, ensuring sustained compliance with international regulatory standards across all Good Practice domains. You will drive proactive inspection preparedness, orchestrate cross‑functional audit activities, and embed a culture of continuous improvement within quality systems. This role ensures alignment of global teams on inspection strategy, robust documentation and data integrity, and operational excellence through risk‑based compliance oversight and regulatory intelligence.

Role and 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.

Audit Program Management

• 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.

Inspection Readiness

• 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.

Governance and Reporting

• 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.

Team Leadership

• Build and manage a high‑performing global audit team who demonstrate a growth mindset and make decisions based on the patient.
• Provide coaching, development, and performance management to the team.

Stakeholder Engagement

• Collaborate effectively with Quality, Safety, Regulatory Affairs, R&D, Manufacturing and other functions to ensure proactive inspection readiness.
• Be an active member of the Quality Leadership Team representing audit and inspections.
• Represent the company in regulatory interactions and industry forums.

Qualifications

Education

• Bachelor's or advanced degree in life sciences, pharmacy, or related field.

Certifications or Designations

• Potential QP or QPPV experience.

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.

Knowledge and Skills

• 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.

What we offer in return

• Opportunities for learning & development through our varied programme.
• Collaborative, inclusive work environment.

Diversity and inclusion. Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn't just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect.

About Mundipharma. Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient‑Centricity, are at the heart of everything they do.

For more information visit www.mundipharma.com..

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Additional Job Description:

Primary Location:

GB Cambridge

Job Posting Date:

2026-01-14

Job Type:

Permanent

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