Location
South Mimms, Potters Bar, Hertfordshire

Hours
Full Time - 37 hours per week

Salary
£46,160 - £51,666 per annum plus benefits

About the Role
We are seeking a Quality Lead to join the Health & Safety and Quality Assurance Function within the Science and Research group at the Medicines and Healthcare Products Regulatory Agency (MHRA). This permanent, full-time role is based at the South Mimms campus. The Quality Assurance Team is responsible for maintaining ISO 17025, ISO 9001, and HTA Quality Management Systems, providing guidance and support to management and scientists to ensure compliance with relevant Standards, Directives, Regulations, and Guidelines.

The successful candidate will manage the Control Testing Quality Management System (QMS) aligned with ISO 17025, WHO, and EDQM requirements. Key responsibilities include providing advice, support, guidance, and training to scientists, conducting audits to improve QMS, ensuring compliance with quality guidelines, and developing and delivering ISO 17025 QMS training programmes. This role plays a vital part in supporting Control Testing and Batch Release testing of biological medicines, ensuring professional excellence and continuous improvement within the Agency.

Experience
- Proven experience working within ISO 17025 Quality Management System (QMS) or equivalent, with a robust understanding transferable to various QMS.
- Experience in leading internal audits, identifying issues, and providing constructive feedback to resolve non-conformities.
- Experience developing, implementing, maintaining, and reviewing systems and services to ensure professional excellence.
- Ability to review and interpret complex scientific data against QMS requirements, test methods, and specifications.

About you
- Strong leadership skills with the ability to provide advice, guidance, and training.
- Excellent problem-solving and troubleshooting abilities.
- Collaborative approach to working with stakeholders to develop improvements.
- Commitment to maintaining high standards of quality and compliance.

Qualifications
- BSc degree in a relevant biological discipline such as biochemistry, microbiology, immunology, or molecular biology.
- Experience with detailed record keeping.
- In-depth practical experience of a broad range of biological laboratory techniques within a Quality Management System.