Medicines and Healthcare products Regulatory Agency
Quality Lead
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We are currently looking for a Quality Lead to join our Health & Safety and Quality Assurance Function within the Science and Research group.
This is a full-time opportunity, on a permanent basis. The role will be based in South Mimms, Hertfordshire.
Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.
Who are we?
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 Quality Assurance Team in the HSQA Function is responsible for maintaining the ISO 17025, ISO 9001 and HTA Quality Management Systems at the MHRA South Mimms campus providing guidance and support to management and scientists to ensure compliance to all relevant Standards, Directives, Regulations and Guidelines.
What’s the role?
The successful applicant will be expected to provide advice, support, guidance and training to Scientists with respect to Quality Management Systems (QMS) to support Control Testing and Batch Release testing of biological medicines work and in particular ISO 17025, WHO and EDQM requirements.
Key responsibilities:
- Day to day management of the Control Testing Quality Management System (QMS) in line with the relevant Standards and Agency’s needs and providing advice, support, guidance, direction, training, trouble shooting and problem solving as required.
- Carry out audits to support the Agency’s Quality Management Systems (QMS) and review audit findings to ensure that they add value and continually improve the QMS.
- Ensure that the Agency’s Control Testing activities comply with the requirements of ISO 17025, WHO and EDQM Quality Management Guidelines and when necessary review, develop and implement harmonised QA practices in the Operational Functions with respect to ISO 17025, WHO and EDQM Requirements.
- Develop co-ordinate and deliver the ISO 17025 QMS training programme to support the QMS and ensure that staff at the South Mimms campus understand their responsibilities when carrying out Control Testing activities.
Who are we looking for?
Our successful candidate will:
- BSc in a relevant biological discipline e.g. biochemistry, microbiology, immunology, molecular biology and experience of detailed record keeping.
- Proven experience, awareness and understanding with working within the ISO 17025 Quality Management System (QMS) or equivalent and a robust understanding of the requirements that can be transferred to a variety of QMS.
- Experience of developing, implementing, maintaining and reviewing systems and services to ensure delivery of professional excellence, and working with stakeholders to develop suggestions for improvements.
- Experience in leading internal audits and be able to identify issues and provide constructive feedback to auditees as to how non-conformities can be resolved.
- Ability to review and interpret complex scientific data against requirements of a Quality Management System (QMS) and draw conclusions regarding compliance to requirements, test methods and specifications.
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Person Specification:
Method of assessment:
A=Application, T=Test, I=Interview, P=Presentation
Behaviour Criteria:
- Seeing the Big Picture (A, I)
- Leadership (A, I)
- Changing and Improving (A, I)
- Working Together (A, I)
Experience Criteria:
- Proven experience, awareness and understanding with working within the ISO 17025 Quality Management System (QMS) or equivalent and a robust understanding of the requirements that can be transferred to a variety of QMS (A, I, P)
- Experience in leading internal audits and be able to identify issues and provide constructive feedback to auditees as to how non-conformities can be resolved (A, I)
- Experience of developing, implementing, maintaining and reviewing systems, services and processes to ensure delivery of professional excellence, and working with stakeholders to develop suggestions for improvements (A, I, P)
Technical Criteria:
- BSc in a relevant biological discipline e.g. biochemistry, microbiology, immunology, molecular biology and experience of detailed record keeping (A, I)
- In-depth practical experience of a broad range of relevant biological laboratory techniques undertaken within a Quality Management System and reviewing and interpreting complex scientific data against requirements and specifications (A, I)
If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification [https://mhra-gov.filecamp.com/static/files/Bw9xvp8qJ34ZUrsS.pdf]!
Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk.
The selection process:
We use the Civil Service Success Profiles to assess our candidates, find out more here [https://www.gov.uk/government/publications/success-profiles].
- 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.
- Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
- Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
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.
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Artificial Intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance [https://eur01.safelinks.protection.outlook.com/?url=https://www.civil-service-careers.gov.uk/artificial-intelligence-and-recruitment/&data=05|02|Ufuoma.Eriemo2@mhra.gov.uk|3d175bf263f54c3cf85608de3bfa288f|e527ea5c62584cd2a27f8bd237ec4c26|0|0|639014142773052769|Unknown|TWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ==|0|||&sdata=2VE8qZPdzo8azEL775DBoKUPz5zMHopZPjc9cs3KuOk=&reserved=0] for more information on appropriate and inappropriate use.
If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.
Closing date: 4th August 2026
Shortlisting date: from 13th August 2026
Interview date: from 24th August 2026
If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk.
Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here [https://www.gov.uk/government/publications/nationality-rules].
Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks [https://www.gov.uk/government/publications/government-baseline-personnel-security-standard?_ga=2.149328757.2118900794.1613132232-433185063.1580991281].
Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance. These roles include:
- Laboratory-based roles working directly with known pathogens
- Maintenance roles, particularly those required to work in laboratory settings
- Roles that involve visiting other establishments where vaccination is required
- Roles required to travel overseas where specific vaccination may be required.
Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for
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