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.
Qualifications
- 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.
Key Responsibilities
- 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.
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