Regulatory Quality Assurance Manager

Alliance Medical; Portsmouth; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company in Portsmouth seeks a Regulatory Quality Assurance Manager to ensure GMP and regulatory compliance across multiple radiopharmacy sites. The ideal candidate will have a degree or equivalent experience in a related field, a minimum of 5 years' regulatory experience, and proven expertise in GMP and MHRA standards. Responsibilities include overseeing compliance, acting as QA regulatory lead, and ensuring strong quality culture across the UK network. Excellent communication and organizational skills are essential.

Qualifications

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

Responsibilities

• Oversee GMP, GDP and MHRA compliance across multiple radiopharmacy sites.
• Act as QA regulatory lead for Commercial and IMP activities.
• Support MHRA and regulatory authority interactions, including inspections.

Skills

Regulatory Quality Assurance

GMP

Attention to Detail

Communication Skills

Organizational Skills

Education

Degree in Quality, Regulatory or Pharmaceutical Discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

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.