Quality Control Manager
The closing date is 24 May 2026
Nottingham University Hospitals (NUH) NHS Trust has identified excellence in research for the benefit of patients as a core component of our corporate vision to be the best acute teaching organization. NUH sponsors and hosts a comprehensive portfolio of Clinical Trials of Investigational Medicinal Products (CTIMPs). NUH aims to develop and maintain robust pharmacovigilance and quality management systems in order to ensure patient safety and data quality during the conduct of clinical trials.
The post holder will assist in maintaining systems to assure the quality of clinical research undertaken within NUH in accordance with the prevailing legislative and best practice requirements.
Job responsibilities
* Assist in maintaining systems to assure the quality of clinical research undertaken within NUH in accordance with the prevailing legislative and best practice requirements, including UK Policy Framework for Health and Social Care for Research, Good Clinical Practice, Medicines for Human Use (Clinical Trials) Regulations, Human Tissue Act, Mental Capacity Act.
* Promote and develop a culture that supports high quality research through help and support to research leaders and their teams.
* Coordinate standards, working practices and policy implementation to ensure compliance with internal policies and external regulatory frameworks, and prepare for external audits and MHRA inspections.
* Contribute to policy development for NUH.
* Ensure GCP and R&I SOP training is completed and records are up to date.
* Maintain precise and accurate quality management records ready for inspection by regulatory bodies and Sponsors.
* Undertake quality control checks of research activity within and on behalf of NUH, including suppliers, BRC Partners, the CRF and Clinical Trials Unit.
* Monitor and support the management of systems to document accountability and traceability of Investigational Medicinal Products (IMPs) in accordance with local SOPs.
* Recognise and respond to research governance and quality issues during quality control checks.
* Respond to departures from legislative and research governance requirements, including reporting serious breaches in accordance with the Medicines for Human Use (Clinical Trials) Regulations.
* Promote a quality culture among NUH and partner researchers.
* Liaise with medical and non-medical staff regarding research quality management issues, maintaining good relationships with academic and service departments to promote effective teamwork.
* Record and report incidents to the R&I board and research teams; ensure necessary reports and notifications are provided to R&I and regulatory authorities.
* Work autonomously and efficiently, maintaining effective communication across NUH where non-compliances have been identified.
* Utilise Trust reporting systems, including DATIX, appropriately.
* Meet regularly with the Research and Innovation Head of Research Governance, Quality and Integrity (HRGQI) to provide feedback on workload and quality management activities.
* Organise and chair regular quality management operational meetings such as monitoring visits and training performance.
* Work in accordance with Trust-wide policies and procedures.
* Assist with information governance or potential fraud and misconduct issues identified through quality control activities or inspections.
* Maintain knowledge of legislation and guidance governing clinical research; attend conferences, training courses, or relevant networks or forums.
* Maintain a high level of knowledge relating to the EU and UK legislation, regulations, management and conduct of research; act as an NUH expert on these matters.
* Maintain personal training records.
* Overall management of R&I GCP documentation: policies, SOPs and forms.
* Prepare, review and approve policies, SOPs and forms ensuring regulatory and Trust requirements are met.
* Manage documentation control and biennial review of SOPs; publish SOPs and forms in correct format and location.
* Identify and report incidents requiring corrective and preventative actions to the Quality Assurance Manager.
* Collaborate with the R&I Workforce Development Team to manage the training matrix for all R&I staff.
* Track compliance of R&I workforce with training matrix.
* Oversee training on policies, SOPs, templates for R&I staff and researchers; document training.
* Provide metrics on training completeness to HRGQI for quarterly reporting.
* Manage retention of staff training records per Trust Policy.
* Provide support and advice to NUH researchers regarding ICH-GCP principles and compliance.
* Assist HRGQI, QA Manager, Research Governance Manager and Workforce Development Team to prepare and deliver targeted training programmes on ICH-GCP, research governance, compliance and quality management.
* Overall management of R&I Approved Vendor system; risk assess vendors following due diligence documentation; approve or reject vendors; review vendors per SOPs.
* Prepare for local inspections and support conduct of inspections; respond to inspection findings and coordinate corrective and preventive actions.
* Develop, maintain and deliver a risk-based monitoring programme for research and pharmacovigilance functions within NUH, ensuring ongoing compliance with research protocols, ICH-GCP, regulatory requirements and NUH SOPs and policies.
* Review risk assessments and monitoring plans; define acceptable error rates; take appropriate actions for any failure to meet required standards.
* Arrange monitoring activities, including pharmacovigilance activities and accountability of IMPs, devices, equipment and clinical samples.
* Ensure monitoring programme is reviewed annually and is risk-based.
* Ensure monitoring reports are complete, oversee completion of any actions, relay findings to appropriate teams; document and disseminate findings within NUH to drive continuous improvement.
* Escalate overdue monitoring visits to research team, HRGQI and senior R&I management where required.
* Assist in preparing complex reports for QC oversight committees, documenting monitoring activities, metrics, findings and resolutions.
* Undertake any other relevant duties appropriate to the grading of the post.
Person Specification
Commitment to Trust Values and Behaviours
* Must be able to demonstrate behaviours consistent with the Trust's "We are here for you" behavioural standards
Training & Qualifications
* Educated to at least Master's degree level / or equivalent experience in a related subject area, e.g. a life science or clinical subject.
* Expert knowledge of: Good Clinical Practice as defined in the Medicines for Human Use (Clinical Trials) Regulations; the Human Tissue Act; the Mental Capacity Act; Data Protection Act (2018) and UK GDPR.
* Knowledge of the clinical trial lifecycle from confirmation of sponsorship through to archiving.
* Evidence of Continuous Personal Development.
* Quality improvement qualification e.g. QSIR.
* Project Management qualification e.g. PRINCE2.
* Understanding of other GCP principles (GxP).
* Understanding of clinical investigations of medical devices (ISO14155).
* Monitoring of Non-Commercial Clinical Research Studies qualification.
Experience
* Experience of the design and management of quality control activities within a clinical research environment.
* Experience within either a pharmaceutical company, contract research organization, NHS or academic setting of risk assessments (including defining and reviewing acceptable error rates); monitoring visits; source data verification.
* Experience of developing, implementing and following standard operating procedures in a clinical research environment.
* Experience of developing and delivering research-related training modules to a variety of audiences both online and in person.
* Experience of implementing a risk proportional approach to quality control activities.
* Proficient IT skills, particularly in the use of Web applications and MS Office applications.
* Experience of presenting complex reports to senior committees or Board-level groups.
* Understanding of the NHS and its research priorities.
* Experience of working within the UK Policy Framework for Health and Social Care Research (2017).
* Experience of quality systems management within clinical research.
* Experience of computer systems validation.
* Knowledge of current national systems and structures for the approval, management and monitoring of clinical research in the NHS.
* Experience of research across a range of therapeutic areas.
* Experience of project management and leading quality improvement initiatives.
* Experience of preparing for and supporting regulatory inspections.
Communication and Relationship Skills
* Ability to influence, negotiate, and support change across teams to embed a just culture and continuous improvement approach.
* Excellent interpersonal and communication skills, with ability to engage effectively with multidisciplinary teams and stakeholders.
* Ability to communicate difficult and sometimes challenging information both orally and in writing, internally and externally to a range of audiences.
* Ability to build excellent working relationships and gain the respect and confidence of others.
* Ability to deliver feedback in a positive and encouraging manner.
* Ability to deal with challenging behaviour from researchers in a calm, diplomatic and professional manner.
* Highly motivated to improve the understanding of Quality among researchers.
Analytical and Judgement Skills
* Strong analytical skills with the ability to interpret complex data, identify themes, and support systems-based learning and improvement.
* Experience of producing high-quality written reports.
* Ability to make judgments regarding a range of highly complex research management issues.
* Strong problem solving and negotiation skills.
* Ability to construct a balanced argument to internal and external parties.
Planning and Organisation Skills
* Ability to plan, manage and deliver complex projects, involving multiple agencies and individuals and a range of tasks.
* Demonstrates attention to detail alongside the ability to extract key learning from complex information.
* Ability to work autonomously, prioritise workload, and translate strategic priorities into operational plans, consistently to tight timelines.
* Flexible approach to working.
Physical Skills
* Physical effort: Frequent requirement to work in a restricted position, when using a computer.
* Mental effort: Frequent requirement for concentration, with an unpredictable work pattern.
* Emotional effort: Occasional exposure to distressing or emotional circumstances, or challenging behaviour.
* Working conditions: Use of computer continuously for prolonged periods on most days.
Other requirements specific to the role
* Ability to travel across both campuses, regionally and nationally to conduct monitoring visits and attend meetings, training and conferences.
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.
Address
Queens Medical Centre, Nottingham University Hospitals NHS Trust
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