Job summary
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
- 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
- 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
About us
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:
- Royal Victoria Infirmary (RVI)
- Freeman Hospital
- Newcastle Dental Hospital
- Cramlington Manor Walks
- Urgent treatment centres
- Newcastle Fertility Centre
- Northern Centre for Cancer Care, North Cumbria
- Northern Genetics Service
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
Job description
Job 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
Job description
Job 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
Essential
- Awareness of fundamental national and local NHS and R&D policies
- Evidence of relevant continuous professional development
SKILLS
Essential
- 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
- Broad IT skills
- Service improvement/change management skills
- Well-developed report writing and analytical and presentation skills
EXPERIENCE
Essential
- 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
Desirable
- Experience in a corporate leadership role
- Extensive of conducting pharmacovigilance audits
QUALIFICATIONS
Essential
- Masters level qualification or equivalent qualification or equivalent experience
Person Specification
KNOWLEDGE
Essential
- Awareness of fundamental national and local NHS and R&D policies
- Evidence of relevant continuous professional development
SKILLS
Essential
- 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
- Broad IT skills
- Service improvement/change management skills
- Well-developed report writing and analytical and presentation skills
EXPERIENCE
Essential
- 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
Desirable
- Experience in a corporate leadership role
- Extensive of conducting pharmacovigilance audits
QUALIFICATIONS
Essential
- Masters level qualification or equivalent qualification or equivalent experience
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
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