Assistant Quality Assurance Manager

Employer heading

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.

Job Overview

We are delighted to offer a challenging and rewarding opportunity to join two leading NHS Hospital Trusts at the forefront of clinical research. This unique role spans Gateshead Health NHS Foundation Trust and The Newcastle upon Tyne Hospitals NHS Foundation Trust, with the post holder dividing their time equally between the two organisations. Within Newcastle there will be a particular focus on supporting the Newcastle Clinical Research Facility (NCRF).

As a key member of the Research & Development teams, you will play a vital role in supporting the development, implementation, and maintenance of robust Quality Management Systems to meet regulatory and accreditation standards.

• Interview Date Friday 17 October 2025
• 37 Hours 30 Minutes/Week
• You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy
  
  

NO AGENCIES PLEASE

Main duties of the job

Working closely with the NCRF Quality Assurance Manager and both Regulatory Compliance Teams, you will ensure that the sponsorship and delivery of clinical trials across both Trusts are conducted to the highest standards of Good Clinical Practice (GCP) and in line with all relevant regulations and guidance.

This Is a Varied And Influential Role Involving

• Providing expert advice on all aspects of research quality assurance and regulatory compliance
• Leading and conducting audits, including site visits to external organisations
• Preparing, approving, and implementing quality assurance documentation
• Delivering training to embed best practice across teams
  
  

You will hold a Master’s degree (or equivalent qualification/experience) and bring strong knowledge of the clinical trial process, GCP, and hands-on experience of quality assurance across diverse research settings. Excellent communication and collaboration skills are essential, as you will work closely with multidisciplinary teams to ensure high-quality, compliant research.

This role offers a unique opportunity to contribute to nationally recognised research excellence, supporting the development and delivery of safe, innovative, and high-quality clinical trials that make a real difference to patients.

Working for our organisation

As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.

Our staff oversee over 6,500 patient contacts every day, delivering high standards of healthcare from the following sites:

• Freeman Hospital
• Royal Victoria Infirmary (RVI)
• Health Innovation Neighbourhood (on the former Newcastle General Hospital and Centre for Ageing and Vitality site)
• Newcastle Dental Hospital
• Newcastle Fertility Centre
• Northern Centre for Cancer Care, North Cumbria
• Northern Genetics Service
• Cramlington Manor Walks
  
  

These include a range of flagship services which deliver cutting-edge care (supported by state-of-the-art diagnostic services in both radiology and pathology) and are a catalyst for innovation to support pioneering clinical practice in the NHS.

We also have offices at Regent Point in Gosforth and community sites.

Please see attached information on what Staff Benefits we have to offer at our Trust under ‘Documents to download’ or ‘Supporting documents’.

For further information on The Newcastle upon Tyne Hospitals NHS Foundation Trust please visit: Careers | Newcastle Hospitals | NHS | Newcastle Hospitals and Newcastle Hospitals NHS Foundation Trust

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.

Employer certification / accreditation badges

Documents to download

• JD & PS (PDF, 188.0KB)
• Newcastle Staff Benefits (PDF, 274.4KB)
• Behaviour and Civility Charter (PDF, 93.8KB)
  
  

Apply online now

Further details / informal visits contact

Name Jonathan Stoddart Job title Research Business Manager Email address Jonathan.stoddart@nhs.net Telephone number 0191 9177263 Additional information

Gill Robson

GCP Quality Assurance Manager

gillian.robson4@nhs.net

0191 2825492