JOB SUMMARY

We are currently looking for an Expert GMP Inspector to join our Standards & Compliance Function within the Healthcare, Quality & Access group.
This is a full-time opportunity, on a permanent basis. The role will be home based with travel to 10 South Colonnade, Canary Wharf London, E14 4PU/South Mimms, Hertfordshire. Please be aware that this role can only be worked in the UK and not overseas. Please be aware that this role can only be worked in the UK and not overseas. We are open to requests for flexible working. Please discuss this with the recruiting manager before accepting an appointment.

JOB DESCRIPTION

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.

PERSON SPECIFICATION

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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SELECTION PROCESS DETAILS

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.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of candidates having a proven track record in conducting GMP Inspections in a regulatory capacity.
Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allow sufficient time. You can view the competencies for this role in the job description.

NATIONALITY REQUIREMENTS

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements

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.