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Regulatory Quality Assurance Manager

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Alliance Medical Ltd

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Location:
United Kingdom , Guildford

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Category:
Consulting

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Contract Type:
Not provided

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Salary:

Not provided
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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.

Job Responsibility:

  • 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

Requirements:

  • 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

Additional Information:

Job Posted:
April 23, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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