Quality Assurance Manager - College of Medicine and Health - 46787 - Grade 8

Position Details

College of Medicine and Health

Location: University of Birmingham, Edgbaston, Birmingham UK

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

Grade: 8

Full Time, Permanent

Closing date: 9th March 2025

UK and International travel may be required for this role

Our offer to you

People are at the heart of what we are and do. The University of Birmingham is proud to have been a part of the City of Birmingham and the wider region for over 100 years, and we are equally proud to be recognised as a leading global university. We want to attract talented people from across the city and beyond, support them to succeed, and celebrate their success.

We are committed to helping the people who work here to develop through our sector-leading Birmingham Professional programme which provides all professional services staff with development opportunities and the encouragement to reach their full potential. With almost 5,000 professional services jobs in a wide range of functions in Edgbaston and in our campus in Dubai, there are plenty of opportunities for you to be able to develop your career at the University.

We believe there is no such thing as a typical member of staff and that diversity is a source of strength that underpins the exchange of ideas, innovation, and debate. We warmly welcome people from all backgrounds and are committed to fostering an inclusive environment where diversity is at the heart of who and what we are, and how we work.

Supporting our people to achieve a healthy work/life balance is important both to our employees and to the success of the University and, depending on the role, we offer a variety of flexible working arrangements. We therefore welcome discussions on all forms of flexible working. In addition, you will receive a generous package of benefits including 40 days paid holiday a year, one paid day a year for volunteering, occupational sick pay, and a pension scheme. We also have three high-quality subsidised day nurseries.

The University is situated in leafy Edgbaston and there are excellent transport links to our beautiful campus, including main bus routes and a train station on site. On campus we have a state-of-the-art sports centre with pool, shops, places to eat and drink, our own art gallery, museum and botanical gardens.

Background

With its broad portfolio of clinical trials and clinical studies, the UOB is one of the leading centres for clinical research in the UK. Within its College of Medicine and Health (CMH) it has two UK clinical research collaboration (UKCRC)-registered specialist clinical trials units; Birmingham Clinical Trials Unit (BCTU) and Cancer Research UK Clinical Trials Unit (CRCTU), responsible for the delivery of a large clinical trial portfolio, and the Clinical Research Compliance Team (CRCT), responsible for ensuring researchers within the University are provided with tools, training and compliance checks that will help the researchers, and the University at large, to meet the applicable standards and regulations applicable to clinical trials and human tissue studies.

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.

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.
• Assist in the preparation and review of reports, inspection dossiers and other formal written documentation relating to BCTU.
• Oversee the management of the BCTU’s training programme and assist in the delivery of training to healthcare professionals, students and clinical research staff.
• Act as the lead contact for QA support to the BCTU.
• Provide expertise support and advice on quality-related queries to CTU staff.
• Support the CTU in dealing with (suspected) serious breaches and other safety issues.
• Develop, implement and oversee corrective and preventative actions to address quality management issues.
• Oversee the management of the BCTU’s monitoring programme and ensure the BCTU QA team undertakes on-site monitoring activities.
• Support the delivery of clinical trials by maintaining up-to-date knowledge of relevant legal and regulatory requirements.
• Develop a national profile as an expert in clinical trials quality management.
• Actively manage equality, diversity and inclusion through monitoring and evaluation.
• Support the University’s sustainability agenda through resource efficient working.
• Any other duties commensurate with the grade.

Required Knowledge, Skills, Qualifications, Experience

• Qualified to degree level (or equivalent) in a relevant biomedical or associated subject plus significant experience in clinical research.
• Authoritative knowledge of the legal and regulatory framework that governs clinical research.
• Substantial experience in developing and/or maintaining quality management systems.
• Proven ability to independently plan, lead, report on and review audits.
• Excellent interpersonal and communication skills.
• Proven analytical and problem-solving skills.
• Highly proficient IT skills, including the MS Office suite.
• High level of self-motivation and personal accountability.
• Excellent people management skills.
• Ability to travel in the UK and internationally on occasion.
• Experience of championing Equality, Diversity and Inclusion in own work area.

Dimensions

Roles at this level provide authoritative professional advice across a range of activities and/or will lead and manage diverse team(s) and resources.

Further Information

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

We believe there is no such thing as a 'typical' member of University of Birmingham staff and that diversity in its many forms is a strength that underpins the exchange of ideas, innovation and debate at the heart of University life.