quality manager Norwich, England
Job description
Applications are invited for a Pharmaceutical Quality Manager for the new Faecal Microbiota Transplant (FMT) Facility at Quadram Institute Bioscience (QIB), Norwich, UK.
Background:
We are seeking to appoint a part time Quality Manager with an interest in human studies to investigate the application of Faecal Microbiota Transplant (FMT) for the treatment of gastrointestinal disorders and other microbiome associated diseases to join the Group of Professor Arjan Narbad. The Narbad Group contributes to the Gut Microbes and Health Programme and has a broad interest in the microbial ecology of the gastrointestinal tract and the role of the complex gut microbiome in health and disease.
QIB is establishing a small facility to be licensed by the MHRA for the manufacture of pharmaceutical products for Faecal Microbiota Transplant (FMT).
The teams at QIB and the Norfolk and Norwich University Hospital (NNUH) have already used FMT to successfully treat patients with recurrent CDI and are planning to further expand the application of this technology.
The role:
Overall responsibility for quality management aspects of developing the QIB FMT Facility to attain and retain MHRA Specials Manufacturing and Investigational Medicinal Products licences to 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 the facility is operational, the Quality Manager will have overall responsibility for maintaining these standards to retain MHRA licensing and be responsible for quality management around the provision of a service to supply specialist medicinal products for the treatment of NHS patients and for clinical trials conducted by QIB Research Teams and NHS Clinicians.
As the FMT Service develops, and if desired, there will be opportunities for the post holder to participate in research on the development of FMT products and to be involved in the relevant clinical trials and to establish links with clinicians and gain transferable skills in NHS-related research.
The ideal candidate:
Candidates should possess a degree, or equivalent, in Pharmacy, Pharmaceutical Sciences, Microbiology or Biological Sciences or Pharmaceutical Technology & Quality Assurance (PTQA) qualification, as well as some practical experience in a Quality Assurance or laboratory environment.
Candidates should have knowledge of regulatory control and Quality Management Systems and an understanding of Risk Management.
Excellent organisational and communication skills are essential.
Additional information:
A detailed job description is available on request.
Salary on appointment will be pro rata within the range £43,550 to £54,900 per annum depending on qualifications and experience. This is a part-time post of up to 18 hours per week for a contract of 5 years. Flexible working hours would be considered.
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 enquires about the post, please contact Arjan Narbad ([email protected]).
Further information and details of how to apply can be found here or contact the Human Resources team on 01603 450814 or [email protected] quoting reference 1004499.
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.
The closing date for applications will be 3 August 2023.
The Quadram Institute Bioscience is a registered charity (No. 1058499) and is an Equal Opportunities Employer.
