The Quadram Institute Bioscience (QIB) is excited to invite applications for the role of Pharmaceutical Quality Manager to join our dynamic team in Norwich, UK. This position offers a unique chance to play a key role in pioneering Faecal Microbiota Transplant (FMT) therapies for gastrointestinal disorders and beyond.
Background:
We are seeking to appoint a part-time Quality Manager who is passionate about cutting-edge healthcare solutions and looking for an opportunity to make a real impact in human health research and development, particularly in the area of human studies investigating the application of FMT for the treatment of gastrointestinal disorders and other microbiome associated diseases. This unique role will be part of the Group of Professor Arjan Narbad, contributing to the Gut Microbes and Health Programme.
At QIB, we are leading the way in microbiome research, working to improve health and make a real difference in people's lives. Working in close collaboration with Norfolk and Norwich University Hospital, QIB is establishing an MHRA-licensed facility for the manufacture of pharmaceutical products. The successful candidate will work alongside experts in gut health, microbiology, and pharmaceutical sciences, contributing directly to advancements in FMT therapies.
The role:
As part of our team, the Quality Manager will play a critical role in ensuring the highest standards of quality and compliance in the development and manufacture of FMT products. By overseeing quality control processes, implementing robust systems, and ensuring adherence to regulatory requirements, the Quality Manager will directly contribute to the successful expansion and scaling of this innovative technology.
The Quality Manager will hold overall responsibility for quality management aspects of developing the QIB FMT Facility, ensuring it attains and retains MHRA Specials Manufacturing and Investigational Medicinal Products (IMP) licences. This will facilitate the provision of specialist medicinal products to NHS patients and for clinical trials conducted by QIB Research Teams and NHS Clinicians.
The post holder will contribute to the set-up of the premises, assist in preparation of relevant documentation to meet the required standards and will be involved in consultations with the MHRA during the process to attain licensing. Once operational, the Quality Manager will be responsible for maintaining these high standards to retain MHRA licensing, overseeing quality management for the service that supplies specialist medicinal products for NHS patients and IMPs for clinical trials.
As the FMT Service develops, there will be opportunities for the Quality Manager to engage in research on the development of FMT products, participate in relevant clinical trials, and build strong relationships with clinicians. This role offers a unique chance to gain transferable skills in NHS-related research and contribute directly to advancing FMT therapies.
The ideal candidate:
Candidates should possess a degree, or equivalent, in Pharmacy, Pharmaceutical Sciences, Microbiology or Biological Sciences or a Pharmaceutical Technology & Quality Assurance (PTQA) qualification. Practical experience in Quality Assurance, in a laboratory environment or working knowledge of EU Good Manufacturing Practice Guidelines (GMP) would also be desirable.
Candidates should have knowledge of regulatory control and Quality Management Systems and an understanding of Risk Management. Good attention to detail, and excellent organisational and communication skills are essential.
Additional information:
Salary on appointment will be within the range £44,500 to £55,000 per annum, pro-rata depending on qualifications and experience. This is a part-time post for a contract of 36 months.
Candidates submitting a CV are required to also provide a covering letter which clearly explains your motivation for the application and how you meet the criteria for the post. For informal enquiries about the post, please contact Arjan Narbad (arjan.narbad@quadram.ac.uk).
For further information and details of how to apply, please visit our website https://jobs.quadram.ac.uk or contact the Human Resources team on 01603 450814 or nbi.recruitment@nbi.ac.uk quoting reference 1004844.
Please note, this post does not meet UKVI requirements to provide visa sponsorship.
We are committed to equal opportunities and welcome applications from all sectors of society. The Institute supports equality of opportunity within the workplace and expects all employees to share and display these values. To support our commitment, we have a range of family, faith and diversity friendly working arrangements to help all staff achieve excellence in their area of work.
As a Disability Confident employer, we guarantee to offer an interview to all disabled applicants who meet the essential criteria for this vacancy.
About the Quadram Institute:
The Quadram Institute is a new interdisciplinary research institute dedicated to understanding how food and microbes interact to promote health and prevent disease. Its mission is to deliver healthier lives through innovation in gut health, microbiology, and food. A partnership between Quadram Institute Bioscience, the University of East Anglia, the Norfolk and Norwich University Hospital, and BBSRC, it brings together scientists and clinicians in a state-of-the-art building on the Norwich Research Park. This is one of Europe’s largest centres of life sciences and home of the John Innes Centre and The Earlham Institute. (https://quadram.ac.uk/).
The closing date for applications will be 6 March 2025.
The Quadram Institute Bioscience is a registered charity (No. 1058499) and is an Equal Opportunities Employer.
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