Medical Device Vigilance Manager jobs

We’re looking for someone with a strong background in quality assurance within a pharmaceutical or radiopharmaceutical environment. You will be confident operating across multiple sites and engaging with stakeholders at operational and senior levels.

Required skills and experience:

• Degree or equivalent experience in Quality, Regulatory, or a pharmaceutical discipline.

• Minimum of 5 years’ QA experience, ideally within radiopharmacy, sterile manufacturing or aseptic processing.

• Proven experience with GMP, MHRA expectations and broader GxP requirements.

• Previous managerial experience with a demonstrable track record of strong performance is highly desirable.

• Experience of other roles such as Production/QC or QA in a radiopharmaceutical setting is desirable but not essential.

• Experience supporting commercial and IMP product development, including clinical trial supply.

• Strong understanding of regulatory inspections and authority interactions.

• Experience working across multi-site operations with consistent quality standards.

• Excellent communication, organisational and interpersonal skills.

• Strong attention to detail, proactive approach and ability to work independently.

• Proficiency in Microsoft Word, Excel, PowerPoint and general Windows applications.

In this role, you will provide and quality leadership to our Guildford Radiopharmacy and wider UK network, supporting both routine commercial manufacturing and product development. You will work collaboratively with senior QA colleagues and site teams to ensure consistent quality systems, robust regulatory compliance and continuous improvement across the network.

Key responsibilities include:

• Active member of the Quality Department and Site Management Team, representing the interests of QA and act as the Quality Assurance lead on site.

• As a member of Quality Leadership, work with the Operational Management Team to ensure the Local and Global Quality Systems operate in accordance with Good Manufacturing Practice promoting continuous improvement and consistency across the business.

• Day to day supervision of Quality Assurance Officers, Document Controller and Admin and Quality Support Officer including management of absence, sickness and overtime.

• Support the introduction and development of an eQMS and/or LIMS system.

• Overseeing GMP, GDP and MHRA compliance.

• Supporting MHRA and regulatory authority interactions, including inspections, audits and follow-up commitments.

• Maintaining site licences, variations and regulatory submissions in line with operational needs.

• Harmonising quality systems across sites, including deviations, CAPAs, change control and documentation.

• Providing QA input into product development, validation and technology transfer activities.

• Reviewing and approving key documentation such as SOPs, validation protocols and batch records.

• Contributing to the implementation of a new electronic QMS.

• Driving inspection readiness and a strong quality culture across the UK network.

• Deputising for the Senior QA Manager when required.