Employer The Newcastle upon Tyne Hospitals NHS Foundation Trust Employer type NHS Site Regent Point Town 317 Regent Point Salary £55,690 - £62,682 per annum Salary period Yearly Closing 08/01/2026 23:59 Interview date 29/01/2026
Quality Assurance Manager
Band 8a
Newcastle Hospitals NHS Foundation Trust is one of the busiest and largest NHS hospital trusts in the country. We have around 16,000 staff and an annual budget of £1.7 billion.
With strong history of providing high quality care, clinical excellence, research and innovation regionally, nationally and internationally, w e’re in the top five providers of specialised health services in the country.
As well as providing a wide range of hospital and community services, we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
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 pleased to advertise the vacancy of Quality Assurance Manager for the Clinical Research Directorate. Based within the Newcastle Joint Research Office (NJRO), the post holder will be responsible for the oversight of the department’s Quality Management System (QMS) and annual audit plan. The post holder will support several teams across the NJRO with regulatory and governance affairs and provide strategic input on the future direction of the department.
The post holder will also interact with all delivery teams across the directorate, providing advice, support and key decision making, in relation to quality and audit. The post holder will also lead a team of quality assurance specialist in the areas of Good Clinical Practice (GCP) and Human Tissue Authority (HTA). A key element of the role is to support the Directorate with regulatory inspections and provide advice across several key stakeholders, within Newcastle Hospitals but also across regional partner organisations.
* Interview Date Thursday 29 January 2026
* 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
* Ensure that the annual audit plan is approved and completed
* Provide data in relation to key audit findings and solutions to the Senior Management Team
* Ensure that the quality policy and manual are maintained and fir-for-purpose
* Provide support and advice for processes and standard operating procedures
* Support the NJRO Lead with key decision making and strategy
* Provide line manager for a mixed team of Newcastle Hospitals and Newcastle University staff
* Report to appropriate committees and boards
* Provide key advice and support for regulatory inspections
* Be a key player in Corrective and Preventative planning
* Ensure risk assessments are completed for particular regulatory and governance matters
* Work closely with external stakeholders to ensure quality across partners within the North East and North Cumbria
* Support the Directorates approach to digitalisation
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.
With around 2 million contacts with patients every year, we deliver care from:
* Northern Centre for Cancer Care, North Cumbria
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 will support the Head of the Joint Research Office in leading, developing and coordinating quality management systems in support of the research activity taking place on behalf of the Trust, ensuring patient safety and research data validity, including:
* Ensuring all processes contributing to the performance of any trials are conducted in accordance with ICH-GCP guidelines, relevant SOPs and other regulations.
* Developing a Quality Management System, the focus of which is to develop, perform and manage quality assurance-relates activities from policy level through to coordinating appropriate SOP development, ensuring compliance via undertaking a risk-adaptive audit programme
* Ensure that audit results are formally and consistently recorded and reported and that corrective/preventive actions have been requested and documented effectively
* Training of JRO staff and others as required (either directly or indirectly) regarding GCP, QA and regulatory audits
The post holder will ensure that Sponsor and Regulatory audits are effectively executed and provide support and direction during the hosting of such audits as necessary, assisting the Research Governance Manager as required
Person specification
KNOWLEDGE
* Awareness of fundamental national and local NHS and R&D policies
* Evidence of relevant continuous professional development
SKILLS
* Excellent interpersonal and communication skills
* Organisation and planning skills
* Leadership and management skills
* Negotiation, persuasion and problem-solving skills
* Project management skills and knowledge
* Research and audit skills
* Well-developed report writing and analytical and presentation skills
EXPERIENCE
* Extensive theoretical and practical experience of research governance, audit and policy development in a range of settings to Masters level or equivalent
* Proven experience in a GCP environment and/or quality setting, including policy developments
* Experience of preparing for external inspection
* Experience of monitoring compliance with national risk management/quality standards
* Ability to work strategically
* Experience in a corporate leadership role
* Extensive of conducting pharmacovigilance audits
QUALIFICATIONS
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.
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