Applications are invited for the position of Quality Assurance Manager, Radiopharmaceutical Unit (RPU). Wolfson Brain Imaging Centre (WBIC) a Major Research Facility within the Department of Clinical Neurosciences on the Cambridge Biomedical Campus. The key function of the RPU is to manufacture short-lived radiopharmaceuticals to the high standards of Good Manufacturing Practice (GMP) for the clinical imaging technique of Positron Emission Tomography (PET).
The successful candidate will be responsible for the Quality Assurance framework for PET radiopharmaceuticals, including implementing the requirements of GMP for obtaining and retaining the WBIC's regulatory manufacturing licences (Specials and IMP). The post holder will also be assigned a formal regulatory role with ultimate responsibility for the quality control and release of radiopharmaceuticals for human use as required under relevant WBIC licences. This is a particularly key role at the current time, as the RPU transitions its production processes to refurbished lab space and equipment.
The post holder will have a key role in designing, implementing and monitoring the proper adoption by all RPU staff of new processes to ensure quality-controlled production of radiopharmaceuticals in this state-of-the-art lab environment. The QA manager of the RPU will also liaise effectively with WBIC, CUHT and other external colleagues responsible for administering WBIC RPU radioligands, to ensure that the quality framework extends seamlessly from the lab to the patient.
The QA Manager will have line management responsibility for the QA staff functions, creating and maintaining a positive and supportive working culture across the RPU, ensuring efficient and effective working to deliver the overall performance objectives of the RPU. The QA Manager will lead on development of a robust and effective quality culture in RPU.
We are looking to attract a dynamic and accomplished manager to deliver this key role as part of the exciting and growing PET and radiochemistry environment in Cambridge. Further particulars are detailed at www.wbic.cam.ac.uk. We are happy to discuss the position informally with potentially interested candidates.
Closing Date: 13th December 2023 Informal enquiries should be directed to:Linda Morgan, Business Manager Tel: 01223 331820 Email: firstname.lastname@example.org
Prof Graham Smith, Head of Radiopharmaceutical Unit Email: email@example.com
If you have any queries regarding the application process, please contact ClinNeuroHR@medschl.cam.ac.uk.
Please ensure that you upload a covering letter and a CV in the Upload section of the online application. The covering letter should outline how you match the criteria for the post and why you are applying for this role. If you upload any additional documents which have not been requested, we will not be able to consider these as part of your application.
Please include details of your referees, including email address and phone number, one of which must be your most recent line manager.
Please quote reference SR39622 on your application and in any correspondence about this vacancy.
The University actively supports equality, diversity and inclusion and encourages applications from all sections of society.
The University has a responsibility to ensure that all employees are eligible to live and work in the UK.