Quality Lead HTA Human Application

We are currently looking for a Quality Lead HTA Human Application to join our Health & Safety and Quality Assurance 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. Please be aware that this role can only be worked in the UK and not overseas.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Please discuss this with the recruiting manager before accepting an appointment.

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 Science & Research Group (NIBSC-MHRA) delivers public health impact, world-leading regulatory research innovation, biological standards and medicines control testing. It is divided into 4 Functions, Research and Development, Standards Lifecycle, Control Testing and Quality Assurance and Health & Safety.

The Quality Assurance Team in the HSQA Function is responsible for maintaining the ISO 17025, ISO 9001 and Human Tissue Authority (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.

Role Purpose

The successful applicant will be responsible for ensuring where applicable, that the Agency’s South Mimms site adheres to the appropriate Quality Standards, Directives, Regulations and Guidelines to maintain certification and safeguard the quality of service provided.

This role will be supporting activities undertaken under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 by The UK Stem Cell Bank (UKSCB). The UKSCB has been in operation for over 20 years and was setup by the House of Lords Select Committee to ensure ethical use and quality of human embryonic stem cells for both research and clinical application. It has over 180 lines deposited, with over 30 lines considered of clinical grade. Many of these have been banked by the UKSCB and are being steadily released for use in advanced cellular therapies to treat a range of diseases from hearing and vision loss to cancer and diabetes. We also work with research teams across the Science and Research group to develop areas of improved banking and standardisation and our expert team can offer regulatory guidance to our customers across the healthcare sector.

The precise duties required by the post will vary with the needs of the Team and the strategic objectives of the Agency, but the main responsibilities will include the day-to-day management and development of the HTA (Human Application) Quality Management System (QMS) in line with the requirements of the HTA (Human Application) Codes of Practice, standards and legislation, the QMS and other related Standards and Agency needs.

The successful applicant will be expected to provide advice, support, guidance and training to Scientists with respect to Quality Management Systems (QMS) to support HTA (Human Application) requirements.

Key responsibilities and results areas

Leadership and management

• Day to day management of the HTA (Human Application) 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.

Service delivery

• 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.

Service improvement

• Ensure that the Agency’s activities comply with the requirements of HTA (Human Application) Codes of Practice, standards and legislation and when necessary review, develop and implement harmonised QA practices in the Operational Functions with respect to HTA Requirements.

Quality and Assurance

• Develop co-ordinate and deliver the HTA (Human Application) QMS training programme to support the QMS and ensure that staff at the South Mimms campus understand their responsibilities when carrying out relevant activities.
• Develop the HTA (Human Application) QMS through analysis of data from across the activities, drawing conclusions and feeding back recommendations to continually improve the QMS.

General

• To work independently within assigned tasks and take on additional responsibility within the QMS to support activities once fully trained.

BSc in a relevant biological discipline e.g. biochemistry, microbiology, immunology, molecular biology and experience of detailed record keeping.

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) (opens in a new window)
• 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 (opens in a new window)

This vacancy is using Success Profiles (opens in a new window), and will assess your Behaviours, Strengths, Experience and Technical skills.

Key dates

• Closing date – 1 December 2026 at 23:55
• Sifting – from 3 December 2026
• Main panel interviews – from 14 December 2026

Communications will be electronic via email therefore it is important that you check your Civil Service Jobs account regularly, as well as your spam/junk email folder.

We’re committed to being diverse and inclusive, so please make your application anonymous by removing all identifying personal information (such as names and dates) from your employment history and personal statement.

What will the process look like?

1. Sift Stage

The main sift, where we'll read and score your application. This may involve a large number of applications, please bear with us as this can take some time.

• Anonymised CV which sets out your career history, previous experience and skills, highlighting specific responsibilities that are relevant for this role.
• 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.

The panel will look at your application and are looking for evidence of the stated points. We may raise the benchmark score required if we receive a high number of applications.

2. Main Panel Interview

Successful candidates from the sift stage will be invited to attend an interview. We use a blended interview technique, allowing us to find out more about you. We use the Success Profile framework and at interview we will be assessing Behaviours and Experience.

Your interview will include:

• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.

At interview, we will be asking questions relating to the following:

• Behaviours, as listed in the person specification
• Technical, as listed in the person specification
• Experience, as listed in the person specification
• Strengths

Feedback will only be provided if you attend an interview.

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.

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.

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.

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 carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.

Individuals appointed on level transfer will retain their existing salary and are responsible for ensuring they fully understand the financial implications of any potential move and the impact (if any) on their terms. If an individual is in any doubt, they should seek clarification before accepting a job offer.

Staff joining on promotion will receive up to a 10% increase of their current basic salary, or the pay band minimum, whichever is the greater.

The individual will not retain any allowances paid by the former department/Agency, unless there are special circumstances, such as a reserved right to those allowances on transfer.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.

Feedback will only be provided if you attend an interview or assessment.