Quality Assurance Manager

We have a fantastic opportunity for a Quality Assurance Manager to join our Radiopharmacy Quality Team.

In this role, you will maintain the AMRP (UK) Quality Management System (QMS) with a focus on standardizing and continually improving processes and procedures to ensure compliance with Good Manufacturing Practice (GMP) and regulatory guidelines. Building and maintaining strong working relationships across UK sites is essential.

You will manage Manufacturing, Marketing, and Wholesale Dealer Authorisations through Regulatory Consultants to maintain licenses and Marketing Authorisation (MA) variations, and work with Pharmacovigilance consultants to manage Pharmacovigilance for AMRP. Additionally, you will deputize for the Head of Quality (HoQ) for UK QA-related issues in the absence of the HoQ or the Deputy Head of Corporate Quality (DHoCQ).

You will work closely with the Head of Quality (HoQ), Deputy Head of Corporate Quality (DHoCQ), and QA Managers to maintain the Quality Management System (QMS) and oversee its core processes and procedures, including Deviations, Change Controls, Complaints, CAPAs, and OOS.

You will support Global Quality Management Meetings, ensuring timely closure of actions, and continually improve the QMS to comply with GMP and regulatory guidelines. Ensuring all Responsible Person Units (RPUs) are inspection-ready, participating in site client audits and regulatory inspections, and preparing responses to MHRA inspections or client audits are key responsibilities.

You will advise site teams on Quality and Continual Improvements, assist in implementing a new electronic Document/Quality Management System, and ensure all documentation aligns with relevant guidelines and project plans. Additionally, you will support validation activities, coordinate and conduct internal audits, participate in the supplier audit program, and mentor Quality Associates. Acting as Responsible Person for Importation and handling other tasks as required by management are also part of your role.

Minimum Qualifications

• Degree or higher in relevant scientific area or equivalent experience in a pharmaceutical setting.

Experience

• A strong background in Quality Assurance ideally within radiopharmaceuticals with a minimum of 5 years’ experience.
• Previous managerial or supervisory experience with a demonstrable track record of strong performance is highly desirable.
• Experience of other roles such as Production/QC or QA in a radiopharmaceutical setting is desirable but not essential.

Skills

• Experience of Pharmacovigilance (desirable).
• Experienced in Microsoft Windows, Word, Excel and PowerPoint.
• First class written and communication skills.
• Understanding of PrOFS.
• Excellent interpersonal skills; personable.
• Excellent organisational skills.
• Excellent timekeeping.
• Excellent attention to detail.
• Excellent listening skills.
• Self-motivated.
• Able to work on own; proactive including both defining and executing tasks.
• Leads by example.
• Good regulatory knowledge (GMP, Safety).

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.