Quality Assurance Manager

Salary: Full time starting salary is normally in the range £46,485 to £55,295 with potential progression once in post to £62,098

Role Summary

An exciting opportunity has arisen for an experienced Quality Assurance (QA) Manager to provide pivotal QA support within the BCTU. You will be responsible for overseeing the compliance reviews programme (including audits), the CTU QMS training programme and, in collaboration with the QMS Manager, the BCTU’s quality management system. You will be part of a team of professionals, including members of the CRCT, providing input in and support to the wider QA function across the clinical research arena. 

Main Duties

• In close collaboration with other senior colleagues, provide effective leadership and management of the BCTU QA team supporting compliance delivery.
• Oversee the development and delivery of a risk-based programme of compliance reviews including audits across the portfolio of clinical research activity conducted in and/or on behalf of the BCTU. This includes both internal and external compliance visits and facilitating external compliance reviews within the BCTU. When required, assist in the delivery of audits. 
• Monitoring the unit’s ability to meet quality, audit, and regulatory requirements by providing regular surveillance and analysis of key metrics within the Quality Management System (QMS).
• Developing and maintaining the QMS to ensure it meets all necessary standards.
• Leading quality assurance initiatives and promoting a culture of continuous improvement.
• Ensuring compliance with regulatory requirements in a clinical trial setting.
• Collaborating with various stakeholders to manage the effective and efficient delivery of services.

Person specification

• Qualified to degree level (or equivalent) in a relevant biomedical or associated subject plus a significant experience working in clinical research, or substantial relevant experience evidencing the experience required in this role.
• Authoritative knowledge of the legal and regulatory framework that governs clinical research. Must be able to demonstrate a good understanding of regulated clinical research a non-commercial setting.
• Substantial experience in developing and/or maintaining quality management systems (preferably within a clinical trial setting). Experience writing SOPs is essential.
• Proven ability to independently plan, lead, report on and review audits within a quality assured environment.
• Substantial experience of engaging, and collaborating, with internal and external stakeholders.
• Excellent interpersonal and communication skills, including orally and in writing, with the ability to influence and negotiate effectively with a range of stakeholders
• Proven analytical and problem-solving skills that will help to identify and implement improvements and efficiencies across the project or projects you work on.
• High level of self-motivation and personal accountability with ability to plan and deliver goals to deadlines under pressure.

Informal enquiries to Wilma van Riel, email: w.c.vanriel@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.

Advert information