Regulatory Quality Assurance Manager
About The Role
Please note that we will be interviewing throughout the duration of this advert. Therefore, if you are interested in this role an early application is advised as we may close the advert prior to the advertised date.
Skills And Experience
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.
Required skills and experience:
- 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.
About Alliance Medical
Alliance Medical are Europe’s leading independent provider of imaging services.
We combine service excellence and innovative imaging technologies to improve patient care and support NHS and independent organisations with their ongoing imaging requirements. Our approach has delivered consistent company growth for more than 30 years.
We live by our company values to ensure the highest level of patient care:
Our Values
Leaders, managers, and supervisors have a particular responsibility to be role models in terms of how they demonstrate these values themselves and how they engage their teams to work in this way.
Collaboration:
We work together and in partnership for all our patients. We respect expertise and combine it to achieve more.
Excellence:
We never compromise. We strive to deliver the very best in everything we do to ensure the highest quality of care. We treat our patients and each other with compassion, dignity and respect.
Learning:
Knowledge and understanding comes from learning. At Alliance Medical we are committed to ensuring that each and every one of us keeps on learning and that we continuously look for improved ways of working.
Efficiency:
Efficiency in healthcare means more patients get better care. We constantly seek new ways to use the scarce resource of healthcare more intelligently so that more people can live longer, fuller lives.
Openness:
We act with transparency and honesty in everything we do, where staff are encouraged to speak up to ensure a safe and secure environment for our patients.
Main duties of the role
In this role, you will provide regulatory and quality leadership across our UK radiopharmacy operations, supporting both routine commercial manufacturing and investigational medicinal product (IMP) 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:
- 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.