Pharmaceutical Quality Manager

Job Title: Pharmaceutical Quality Manager

Post Number:

Closing Date: 6 Mar 2025

Grade: SC5

Starting Salary: £44,500-£55,000 (Salary will be pro-rata, based on a full-time 37 hour week)

Hours per week: 22.5

Project Title: QIB FMT Quality Manager

Duration: 36 Months

Flexible Options: Although full-time hours are available, applications from those interested in working part-time hours are also welcomed.

Job Description 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 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 the 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

1. Management of the Pharmaceutical Quality System: 50%
2. Quality Control: To oversee and/or undertake the routine Quality Control activities within the FMT Unit: 20%
3. The overall management and development of the validation program: 5%
4. Monitoring Environmental and Storage Conditions and external services: 5%
5. Day to day management of all personnel assigned to the FMT Facility to perform quality assurance related duties: 5%
6. Research and Development: Participation in the development and validation of new processes for the manufacturing and quality assessment of FMT products: 5%
7. 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%
8. As agreed with the line manager, any other duties commensurate with the nature of the post: 5%

Person Profile Education & Qualifications

Requirement Importance

1. Degree, or equivalent, in a relevant scientific discipline, i.e. Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Microbiology: Essential
2. Management certificate or diploma: Desirable
3. Pharmaceutical Technology & Quality Assurance (PTQA) qualification: Desirable

Specialist Knowledge & Skills

Requirement Importance

1. Knowledge of Quality Management Systems: Essential
2. Regulatory control / governance: Essential
3. Principles of Good Manufacturing Practice, Good Laboratory Practice and Good Distribution Practice: Essential
4. Practical experience of microbiology: Essential
5. Quality audit techniques: Desirable
6. Training and competency assessment: Desirable
7. Pharmaceutical Quality Assurance/Quality Control: Desirable
8. Environmental/Microbiological/Contamination control: Desirable
9. Validation: Desirable
10. Regulations for conducting clinical trials under an MHRA IMP licence: Desirable
11. Knowledge of Risk Management: Desirable

Requirement Importance

1. Practical experience in a pharmaceutical manufacturing or laboratory environment: Essential
2. Experience of the manufacture and/or quality assessment of pharmaceutical products: Essential
3. Practical experience of MHRA licensing of pharmaceutical manufacturing and/or aseptic dispensing: Desirable
4. Practical knowledge of FMT procedures: Desirable
5. Experience of working in GMP manufacturing facility: Desirable

Management and Leadership

Requirement Importance

1. Management experience: Desirable

Interpersonal & Communication Skills

Requirement Importance

1. Good communication skills, both written and verbal: Essential
2. Able to work independently and proactively: Essential
3. Good organisational and management skills: Essential
4. Ability to manage changing priorities and a fluctuating workload: Essential
5. Self-motivated and willing to learn: Essential
6. Good interpersonal skills, with the ability to work well as part of a team: Essential

Additional Requirements

Requirement Importance

1. Attention to detail: Essential
2. Promotes equality and values diversity: Essential
3. Willingness to embrace the expected values and behaviours of all staff at the Institute, ensuring it is a great place to work: Essential
4. Ability to maintain confidentiality and security of information where appropriate: Essential
5. Willingness to work outside standard working hours when required: Essential
6. Able to present a positive image of self and the Institute, promoting both the international reputation and public engagement aims of the Institute: Essential

Who We Are 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 (0) or .

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.

The closing date for applications will be 6 March 2025.

The Quadram Institute Bioscience is a registered charity (No. ) and is an Equal Opportunities Employer.