Regulatory Quality Assurance Manager

We are looking for a highly skilled Regulatory Quality Assurance Manager to join Alliance Medical Radiopharmacy UK. Sitting within our UK Quality function, this role reports directly to the Head of Quality UK and plays a key part in ensuring GMP and regulatory compliance across our network of seven licensed radiopharmacy sites.

You will act as a central link between Quality Assurance, Regulatory Affairs, Operations and external regulatory authorities-helping us maintain the highest standards of patient safety, operational excellence and regulatory readiness.

We're looking for someone with a strong background in regulatory 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.

• Degree or equivalent experience in Quality, Regulatory, or a pharmaceutical discipline.
• Minimum of 5 years' regulatory experience, ideally within radiopharmacy, sterile manufacturing or aseptic processing.
• Proven experience with GMP, MHRA expectations and broader GxP requirements.
• 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.

• Overseeing GMP, GDP and MHRA compliance across multiple radiopharmacy sites.
• Acting as QA regulatory lead for Commercial and IMP activities, including IMPD reviews and clinical trial processes.
• 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 Head of Quality when required.