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.

Find out more about the benefits of working for the University of Birmingham

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.

Both CTUs and the CRCT work closely with the Research Ethics, Governance & Integrity Team (REGI) that is responsible for coordinating the University’s internal ethical review processes and acts as the University’ sponsor representative. In its role as a sponsor/hosting institution for clinical research, the UOB has set up an infrastructure to maintain appropriate oversight, consisting of committees, groups and teams who are fully committed to delivering high-quality clinical research. 

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. 
• Assist, and when required take a lead, on 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. When required 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. This may include some or all of the following activities listed below.
  • Providing expertise support and advice on quality-related queries to CTU staff and communicating relevant quality related issues to the CTU’s oversight group.
  • Supporting the CTU in dealing with (suspected) serious breaches and other safety issues, and where required lead on the reporting to appropriate bodies.
  • Providing updates to the CTU’s oversight group on the changes to the statutory and regulatory framework, and where necessary making recommendations for changes in practice within the CTU.
  • Supporting the CTU for inspection readiness and liaising with auditors and inspectors as required during CTU-specific audits and inspections.
  • Providing support in the assessment of and reporting of deviations, suspected serious breaches and safety issues where required. If necessary, signing the deviation form.
  • Developing, implementing and overseeing any corrective and preventative actions to any address quality management issues, in particular QMS-related deviations.
  • Carrying out archiving responsibilities as defined in the QMS.
• Oversee on the day-to-day review, development and maintenance of the BCTU’s QMS in close collaboration with the QMS Manager the Clinical Research Compliance Manages. This may include some or all of the following activities listed below.
  • Taking responsibility for developing and updating policies, standard operating procedures (SOPs) and tools within the system.
  • Reviewing documentation to ensure the University meets all applicable regulatory requirements.
  • Reporting on progress, including the development of reporting mechanisms, writing reports (e.g. on proposed changes), and presenting to appropriate meetings such as oversight committees or to other key stakeholders.
  • Stakeholder management, ensuring effective liaison with (for example) researchers, managers, topic leads as appropriate.
  • Acting as a final reviewer and authoriser of documents.
  • In collaboration with other senior colleagues, identify training needs for each QMS document, and deliver training as required. 
• Oversee the management of the BCTU’s monitoring programme. When required, ensure the BCTU QA team suitably undertakes on-site monitoring activities.
• Oversee the archiving of BCTU’s clinical trial data. 
• Support the delivery of clinical trials by maintaining up-to-date knowledge of relevant legal and regulatory requirements, and accepted quality standards. The regulations and standards may include but are not limited to those listed below.
  • The Medicines for Human Use Clinical Trials Regulations, Medical Device Regulations, Data Protection Act, Human Tissue Act.
  • Good Clinical Practice (GCP) and GCP in the Laboratory, the Declaration of Helsinki.
  • UK Policy Framework for Health and Social Care Research.
  • Caldicott Principals.
  • University policies and procedures, including, but not limited to the UOB Data Protection Policy, Information Security Policy and Code of Practice for Research.
• Develop a national profile as an expert in clinical trials quality management. Contribute to local, national and international activities (e.g. within the UOB, Birmingham Health Partners, National Institute for Health Research, MHRA) through participation in national working parties, committees and by presenting at meetings. 
• Actively manage equality, diversity and inclusion through monitoring and evaluation and actively challenging unacceptable behaviour. 
• 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 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, 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.
• Highly proficient IT skills, including the MS Office suite. You should be confident and able to quickly learn new IT skills and software packages as required. Q-Pulse document management system would be an advantage.
• High level of self-motivation and personal accountability with ability to plan and deliver goals to deadlines under pressure.
• Excellent people management skills, with proven experience of leading, motivating and managing teams.
• Ability to travel in the UK and internationally on occasion. Overnight stays between visits may be required occasionally and on occasion trips may include longer stays.
• Ability to monitor and evaluate the extent to which equality and diversity legislation, policies, procedures are applied. 
• Ability to identify issues with the potential to impact on protected groups and take appropriate action.
• 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. You will use your professional skills to resolve problems where the solution is not immediately apparent. Significant evaluation and independent thought are therefore required to resolve ambiguity. You will have wide discretion to decide on direction whilst ensuring activities are broadly consistent with operational policies. You will be able to influence policy through advising on the impact of policy change and implementation in your area of work. You will need to assess the impact of your activities across your area, with related areas and to ensure they fit with the broader objectives of the University. 

Planning and Organising

• provide professional expertise, and manage resources and/or a diverse team;
• integrate and co-ordinate work across different parts of the department/university;
• lead and manage staff who are likely to be carrying out diverse duties, and ensure collaborative working to deliver a successful service;
• project manage activities to facilitate major changes;
• develop policy within functional guidelines, and contribute to strategic development within own area;
• be accountable for the quality and professionalism of service delivery, with an appreciation of longer-term issues.

Problem Solving and decision making

• anticipate, interpret and assess customer needs, identifying trends, generating original ideas and testing innovative solutions;
• deal with significant people management issues such as change programmes;
• resolve issues which may not have arisen before through use of experience and judgement. 

Internal and External relationships

• has an excellent understanding of their own working area and a broad understanding of the contribution other areas make to the success of the University; 
• has an excellent understanding of how the University operates, together with an understanding of how academia operates in the UK;
• demonstrates empathy with the academic endeavour and seeks to encourage others to do so;
• use coaching skills to motivate and develop staff;
• proactively and sensitively manage the performance of their team and create a motivating environment;
• influence others (including across the University) to follow a particular course of action;
• represent the department at internal and external meetings/events/network with colleagues in other institutions to share best practice.

Further particulars can be found here

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

View our staff values and behaviours here 

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. We are committed to proactively addressing the barriers experienced by some groups in our community and are proud to hold Athena SWAN, Race Equality Charter and Disability Confident accreditations. We have an Equality Diversity and Inclusion Centre that focuses on continuously improving the University as a fair and inclusive place to work where everyone has the opportunity to succeed. We are also committed to sustainability, which is a key part of our strategy. You can find out more about our work to create a fairer university for everyone on our website.