GCP and GVP Audit Officer

Mundipharma; Cambridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global healthcare company in Cambridge is seeking a GCP and GVP Audit Officer to ensure compliance with regulations and guidelines. The role involves conducting audits, leading inspection teams, and improving quality systems. Ideal candidates will have over 5 years of auditing experience and strong organizational skills. The position offers a permanent contract and a flexible benefits package.

Benefits

Flexible benefits package

Opportunities for learning & development

Collaborative, inclusive work environment

Qualifications

• Minimum 5 years in GCP/GVP auditing or clinical/pharmacovigilance quality.
• Strong knowledge of ICH-GCP, EU GVP Modules, and global regulatory frameworks.
• Experience with audit planning, execution, CAPA management, and hosting inspections.

Responsibilities

• Plan, conduct, and report GCP/GVP audits.
• Evaluate compliance with ICH-GCP and other global regulations.
• Lead inspection response teams and manage post-inspection activities.

Skills

Attention to detail

Strong organizational skills

Excellent communication and report-writing abilities

Education

Certification in auditing (e.g., ISO, RQA)

Job description

GCP and GVP Audit Officer

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 bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees.

Role and Responsibilities

The GCP/GVP Auditor is responsible for planning, conducting, and reporting audits to ensure compliance with GCP and GVP regulations, guidelines, and internal procedures. The GCP/GVP Auditor will also lead and host external GCP/GVP audits and coordinate with the functional SMEs. This role supports the organization's commitment to quality, patient safety, and regulatory compliance across clinical trials and pharmacovigilance activities.

Audit Execution

• Conduct internal and external GCP/GVP audits (e.g., investigator sites, CROs, vendors, PV systems).
• Evaluate compliance with ICH-GCP, EU GVP Modules, FDA, MHRA, EMA, and other global regulations.
• Identify risks, non‑compliances, and areas for improvement.

Audit Planning & Strategy

• Perform risk assessments to prioritize GCP/GVP audit activities.
• Contribute the GCP/GVP audit needs to the development and maintenance of the company audit programme and schedule.

Reporting & Follow‑up

• Prepare detailed audit reports and communicate findings to stakeholders quickly and efficiently.
• Provide feedback on functionally generated CAPAs, monitor and verify the implementation of CAPAs.

Inspection Leadership

• With functional SMEs, coordinate pre‑inspection activities, including training, documentation review, and facility walkthroughs.
• Lead inspection response teams and manage post‑inspection activities including responses and remediation.
• Lead and host health authority inspections, ensuring readiness and coordination across departments.
• Collaborate with subject matter experts (SMEs) to prepare documentation, responses, and real‑time support during inspections.
• Act as the primary point of contact for inspectors.

Continuous Improvement

• Collaborate with teams to improve quality systems and processes.
• Stay current with evolving regulatory requirements and industry best practices.

Stakeholder Engagement

• Collaborate effectively with the rest of Quality, Safety, Regulatory Affairs, R&D, and other functions to ensure the organisation is inspection ready and proactive in inspection preparation.

What You'll Bring

• Certification in auditing (e.g., ISO, RQA) preferred.
• Minimum 5 years in GCP/GVP auditing or clinical/pharmacovigilance quality.
• Strong knowledge of ICH-GCP, EU GVP Modules, and global regulatory frameworks.
• Experience with audit planning, execution, CAPA management, and hosting inspections.
• Experience interacting with authorities during inspections.
• Attention to detail and critical thinking.
• Strong organizational and time‑management skills.
• Excellent communication and report‑writing abilities.
• Professional integrity and discretion.
• Ability to work independently and collaboratively.
• Good communication and stakeholder management assurance.

What We Offer in Return

• Flexible benefits package
• 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 Details

Primary Location: GB Cambridge

Job Posting Date: 2025-10-24

Job Type: Permanent