GMP Expert Inspector

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.  

The objective of the Healthcare Quality and Access Group is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways.

The Innovation & Compliance function enables innovation and healthcare access across the global product lifecycle by risk proportionate standards development and compliance through the British Pharmacopoeia and MHRA Laboratory, the Compliance Teams, the Inspection Action Group and Devices Audit and Compliance.

What’s the role?

Expert Inspectors perform a crucial role in developing the agency’s GxP inspection strategies & legislation, providing technical leadership, guidance and support to the GxP Compliance Teams. They achieve this through engagement with industry, government and regulatory partners at a national and international level, influencing the global approach to medicines regulation and inspections.

Key responsibilities: 

• To lead the development of the respective GxP Inspection strategies and inspection models linking Agency and Government priorities to the work of the Group and the wider GxP Compliance Teams, including development and integration of enabling inspections supporting innovation.

• To play a role in the leadership of the Compliance Teams as a member of its senior team, providing sound technical leadership to the respective GxP Compliance Team, and to provide support, mentorship (including management should circumstances require) and guidance to Inspectors in the respective GxP Compliance team.

• To represent the Compliance Teams, Group and Agency at national and international level amongst government, national regulators and industry groups, for example influencing the approach to medicines regulations and inspection issues, undertaking high profile presentations at conferences, chairing and participating in project groups.

• To lead the respective GxP horizon scanning activities, provide advice on the required future team direction to prepare for emerging developments and to lead on the development of technical expertise within the respective GxP compliance team.

Who are we looking for? 

Our successful candidate will demonstrate the following:

• Proven track record in conducting GMP Inspections in a regulatory capacity

• Extensive GMP knowledge and technical experience (preferably associated with the manufacture of sterile products, biological products and/or advanced therapies).

• Technical leadership experience

• Effective decision maker

• Excellent communicator and influencer

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! 

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The selection process: 

We use the Civil Service Success Profiles to assess our candidates, find out more here. 

• Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application. 

   

• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles. <