Main Purpose of the Job

QIB is establishing a small MHRA licensed manufacturing facility for Faecal Microbiota Transplant (FMT) products. The post holder will participate in the set up of the premises, assist in preparation of relevant documentation e 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 The post is flexible and there will also be opportunities to participate in research on the development of FMT products.

Key Relationships

The post holder will work closely with FMT Unit Qualified Person, Production Manager , QIB senior laboratory manager Dr Andrea Hinkova, FMT service providers, FMT service users and interact with external regulatory and licensing authorities. They will also interact with clinicians and hospital staff at Norfolk and Norwich University Hospital.

Main Activities & Responsibilities

Percentage

Management of the Pharmaceutical Quality System

50

Quality Control: To oversee and/or undertake the routine Quality Control activities within the FMT Unit,

20

The overall management and development of the validation program

5

Monitoring Environmental and Storage Conditions and external services

5

Day to day management of all personnel assigned to the FMT Facility to perform quality assurance related duties

5

Research and Development: Participation in the development and validation of new processes for the manufacturing and quality assessment of FMT products.

5

Audit and Inspection: implementation of a program of internal audits of Good Manufacturing Practice as required by GMP guidelines and the MHRA, including the preparation of detailed audit reports

5

As agreed with the line manager, any other duties commensurate with the nature of the post

5

Education & Qualifications

Requirement

Importance

Degree, or equivalent, in a relevant scientific discipline, i.e. Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Microbiology

Essential

Management certificate or diploma

Desirable

Pharmaceutical Technology & Quality Assurance (PTQA) qualification

Desirable

Specialist Knowledge & Skills

Requirement

Importance

Knowledge of Quality Management Systems

Essential

Regulatory control / governance

Essential

Principles of Good Manufacturing Practice, Good Laboratory Practice and Good Distribution PracticePractical experience of microbiology

Essential

Quality audit techniques

Desirable

Training and competency assessment

Desirable

Pharmaceutical Quality Assurance/Quality Control

Desirable

Environmental/Microbiological/Contamination control

Desirable

Validation

Desirable

Regulations for conducting clinical trials under an MHRA IMP licence

Desirable

Knowledge of Risk Management

Desirable

Relevant Experience

Requirement

Importance

Practical experience in a pharmaceutical manufacturing or laboratory environment

Essential

Experience of the manufacture and/or quality assessment of pharmaceutical products.

Essential

Practical experience of MHRA licensing of pharmaceutical manufacturing and / or aseptic dispensing

Desirable

Practical knowledge of FMT procedures

Desirable

Experience of working in GMP manufacturing facility

Desirable

Management and Leadership

Requirement

Importance

Management experience

Desirable

Interpersonal & Communication Skills

Requirement

Importance

Good communication skills, both written and verbal

Essential

Able to work independently and proactively

Essential

Good organisational and management skills

Essential

Ability to manage changing priorities and a fluctuating workload

Essential

Self motivated and willing to learn

Essential

Good interpersonal skills, with the ability to work well as part of a team

Essential

Additional Requirements

Requirement

Importance

Attention to detail

Essential

Promotes equality and values diversity

Essential

Willingness to embrace the expected values and behaviours of all staff at the Institute, ensuring it is a great place to work

Essential

Ability to maintain confidentiality and security of information where appropriate

Essential

Willingness to work outside standard working hours when required

Essential

Able to present a positive image of self and the Institute, promoting both the international reputation and public engagement aims of the Institute

Essential

Quadram Institute Bioscience

The Quadram Institute is at the forefront of a new interface between food science, gut biology and health, developing solutions to worldwide challenges in food-related disease and human health.

We are engaged in fundamental and translational food and health research, alongside clinical studies, endoscopy and industry, working together to become a leading international hub for food and health research, combining scientific excellence and clinical expertise, delivering impacts on patient care and accelerating innovation.

The Quadram Institute is a diverse and multicultural scientific community. We thrive on our international and European links, appointing staff from across the world. Any candidate who would like further information on current or anticipated immigration requirements can contact the HR Team on +44 (0)1603 450888 or nbi.recruitment@nbi.ac.uk.

For more information about working at Quadram Institute Bioscience, please click here.

Department

Science Operations

Group Details

The Narbad group at QIB has a broad interest in microbial ecology of the gastrointestinal tract and the role of the complex gut microbiome in health and disease. We are also investigating the application of competitive exclusion in humans to combat bacterial infections. We have interest in modulating the gut microbiome using a number of approaches including the application of faecal microbiota transplants for the treatments of microbiome associated disorders. We work closely with the clinicians at the Norfolk and Norwich University hospital including the group of Dr Ngozi Elumogo, Consultant Microbiologist  at Norfolk to undertake human intervention and clinical trials.

Living in Norfolk

• Visit Norfolk
• Schools in Norfolk
• Childcare in Norfolk

Pharmaceutical Quality Manager

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 enquires about the post, please contact Arjan Narbad (arjan.narbad@quadram.ac.uk). 

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.