Quality Manager

Salary: Full time starting salary is normally in the range £35,880 to £45,163 with potential progression once in post to £47,874. Grade: 7 

This is an exciting opportunity to join the University of Birmingham’s Medicines Manufacturing Facility (MMF). The MMF is a GMP unit licensed by the MHRA and provides support to academic and industry partners developing new therapies, currently focusing on Faecal Microbiota Transplants (FMT) and with the scope to bring in Advanced Therapeutic Medicinal Products (ATMPs) and Medical Devices to its portfolio. The post-holder will manage the day-to-day activity across all areas to ensure the operational delivery of a growing portfolio of work.

The role requires deep expertise in GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) as well as regulatory requirements surrounding IMPs and Specials. The Quality Manager will collaborate cross-functionally, working closely with the Licence Holder, Qualified Person (QP), MMF General Manager, Microbiome Treatment Centre (MTC) Service Manager, Production Managers, Clinical Trial Units (CTUs) and Clinical Research Compliance Teams (CRCT).

Main Duties: 

• Manage and, where appropriate, restructure the Quality Assurance (QA), Quality Control (QC), and Compliance functions.
• Oversee the development, maintenance, and scaling of robust Quality Management Systems (QMS) to ensure compliance with regulatory standards (MHRA, ICH, and other global agencies).
• Ensure compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) across all stages of product development.
• Ensure appropriate validation and qualification activities are performed, including facilities, equipment, processes, and computer systems.
• Lead the MMF’s preparations for regulatory agency inspections and audits (MHRA, etc.), and ensure continued inspection readiness.
• Drive the organisation’s response to inspection findings, and implement corrective and preventive actions (CAPA) as necessary.
• Ensure robust oversight of quality assurance and control activities across internal and external manufacturing and testing sites.
• Establish quality metrics and KPIs to monitor performance and drive continuous improvement.

This is a challenging and specialist role that requires excellent knowledge of the applicable regulations and codes of conduct. Exceptional communication and interpersonal skills are essential in order to interact with managers and staff, UoB Compliance teams, regulatory bodies and customers of the MMF.  

This role requires confidentiality, discretion and the use of initiative. The post holder will ensure that all University, College and Institute policies & procedures are adhered to within their specified area of responsibility.

Person Specification

• Extensive experience in quality assurance roles in pharmaceutical manufacturing settings.
• Educated to Degree level (or equivalent qualifications) or relevant technical qualification and considerable relevant experience. Where no equivalent qualification is held, significant practical relevant experience and expertise in a series of more demanding roles will be required demonstrating the conceptual understanding required.
• Ability to work independently in a fast-paced environment with excellent project management and problem-solving skills.
• Working knowledge and experience of relevant legislation related to Human Medicines, GMP, GDP, validation, data acquisition, storage and processing.

Informal enquiries to Parisa Pordelkhaki, email: p.pordelkhaki@bham.ac.uk 

To download the full job description and details of this position and submit an electronic application online please click on the 'Apply' button above.

Valuing excellence, sustaining investment
We value diversity and inclusion at the University of Birmingham and welcome applications from all sections of the community and are open to discussions around all forms of flexible working.

Closes: 3^rd December 2024 

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