Job vacancy: Assistant Quality Assurance Manager, The Newcastle upon Tyne Hospitals NHS Foundation Trust, 317 02 Royal Victoria Infirmary

Job summary

Main area: 317 R&D Quality Assurance
Grade: Band 7
Contract: Fixed term: 2 years (from date of appointment)
Hours: Full time - 37.5 hours per week
Job ref: 317-2025-31-021

Employer: The Newcastle upon Tyne Hospitals NHS Foundation Trust
Employer type: NHS
Site: Royal Victoria Infirmary
Town: 317 02 Royal Victoria Infirmary
Salary: £47,810 - £54,710 per annum
Salary period: Yearly
Closing: 18/09/2025 23:59
Interview date: 17/10/2025

Assistant Quality Assurance Manager

Band 7

Newcastle Hospitals NHS Foundation Trust is one of the busiest and largest NHS foundation trusts in the country, with around 15,000 staff and an annual budget of £1.6 billion.

We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.

We’re in the top five providers of specialised health services in the country, supporting people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.

Our staff oversee around 6,500 patient contacts each day, delivering high standards of healthcare.

We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people’s race, disability, sex, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.

Newcastle Hospitals are proud to be one of the exemplar organisations across the NHS on sustainability, with a long history of delivering Sustainable Healthcare in Newcastle (Shine) and the first healthcare organisation in the world to declare a climate emergency. Our strategy includes commitments to being Net Zero by 2030, for our direct carbon footprint, and Net Zero by 2040 for our footprint plus. Delivering these ambitions will not be possible without the help, support and action of every single member of our team.

Detailed job description and main responsibilities

The post holder has overall responsibility for directing quality operations across the components of the NIHR Newcastle CRF that includes: the RVI CRF based in the Leazes Wing of the RVI; the Clinical Ageing Research Unit (CARU) at the Campus for Ageing and Vitality; and the Dental CRF in the Newcastle Dental School.
The post holder will play a key role in the formulation and delivering our quality strategy that assures the wellbeing of research participants and the integrity of trial data, in compliance with current legislation and regulatory requirements.
The primary purpose of the post is to establish the processes and operational procedures that will generate the platform for future application to the MHRA Phase I Accreditation Scheme.
The post holder will be responsible for promoting a culture of continuous quality improvement by providing informed guidance and training to staff working within the NIHR Newcastle CRF and involved with its outreach activity.

Person specification

Qualifications & Education

Essential criteria

Masters Level qualification or equivalent qualification or equivalent experience

Knowledge & Experience

Essential criteria

Sound working knowledge of quality assurance and its implementation in practice
Working knowledge of regulatory frameworks and legislation governing the conduct of clinical research. This includes but is not restricted to understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Human Tissue Act (2004) regulations and research ethics
Experience of and/or participation in the audit process in a regulatory controlled environment
Experience of and/or participation in external inspections
An understanding of the clinical trials process
Experience of monitoring compliance with quality standards

Desirable criteria

Knowledge of the MHRA Phase I Accreditation Scheme, with an understanding of the implications for quality systems and how the requirements can be met in hospital-based clinical research units
Evidence of undertaking, co-ordinating or managing clinical research, and demonstrating experience of working on phase I, II and III clinical trials
An understanding of NHS Research and Development (R&D and the overarching NHS R&D strategy)
Experience of conducting audits including site, database, documentation and systems
Knowledge of legislation and regulations governing the safe handling and delivery of advanced therapies
Project Management
Awareness of a clinical/hospital environment

Skills & Abilities

Essential criteria

Excellent written and oral communication skills, including presentations
Excellent interpersonal skills in dealing with a diverse range of staff
Ability to contribute to a team approach and proven experience of working as part of a multi-disciplinary team
Excellent time and workload management skills, with the ability to prioritise, plan and work to agreed timescales and to multitask effectively under pressure, maintaining high quality work

Desirable criteria

Ability to analyse, interpret and compare data
Well-developed IT skills and the ability to interrogate complex systems and understand concepts relating to the maintenance of electronic data and security

Important note on completion of reference section of Application Form

All references from current and previous employers will be sought and must cover a minimum of 3 years employment. Therefore, when completing the reference section of your application form, please give the address, telephone number and work email address of each of your current/previous line managers that cover 3 years employment. Failure to complete this section may result in your application not being processed.

Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first month’s pay.

Candidates who are shortlisted for interview will be contacted by e-mail. You should check your SPAM folders as well as your inbox. If you have not been contacted within 4 weeks of the closing date you should assume your application has been unsuccessful.