Quality Control Manager in Nottingham

Nottingham University Hospitals (NUH) NHS Trust has identified excellence in research for the benefit of patients as a core component of our corporate vision. 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 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 prevailing legislative and best practice requirements, including the UK Policy Framework for Health and Social Care for Research, Good Clinical Practice (GCP), the Medicines for Human Use (Clinical Trials) Regulations, the Human Tissue Act and the Mental Capacity Act. Based at QMC, the post holder will promote and develop a culture that supports high quality research through help and support to research leaders and their teams. They will co-ordinate standards, working practices and policy implementation to ensure NUH and partners are compliant with internal policies and external regulatory frameworks, and will assist in preparing for external audits and MHRA inspections.

With over 19,000 staff, NUH is one of the city’s largest employers and plays a central role in supporting the health and wellbeing of the local population. NUH is active in research, education and innovation. We welcome ideas and value diversity to deliver world-class healthcare.

Responsibilities

• Contribute to policy development for NUH.
• Ensure GCP and R&I SOP training is completed and training records are up to date.
• Maintain precise and accurate quality management records ready for inspection by regulatory bodies and Sponsors on demand.
• Undertake quality control checks of research activity within NUH and with partners, suppliers, BRC Partners, the CRF and the Clinical Trials Unit.
• Monitor and support the management of systems to document accountability and traceability of Investigational Medicinal Products (IMPs)/study drugs, ensuring receipt, storage, dispensing, administration and disposal follow local SOPs.
• Recognise and respond to research governance and quality issues, escalating as required (e.g., report serious breaches under the Medicines for Human Use (Clinical Trials) Regulations).
• Promote a quality culture among NUH and partner researchers; liaise with medical and non-medical staff on research quality management issues.
• Record and report incidents to the R&I board and wider research teams, ensuring reports and notifications reach R&I and regulatory authorities.
• Work autonomously and maintain effective communication across NUH when non-compliances are identified.
• Ensure Trust reporting systems (including DATIX) are used 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 meetings (e.g., Monitoring visits, Training performance).
• Work in accordance with Trust-wide policies and procedures; assist with information governance or potential fraud/misconduct issues identified through quality control or inspection.
• Maintain knowledge of legislation and guidance governing clinical research and quality management, through conferences, training or relevant networks.

Education and Training

• Maintain a high level of knowledge relating to EU and UK legislation, regulations and conduct of research; act as an NUH expert on these matters.
• Maintain personal training records.

Documentation Management

• Overall management of R&I GCP documentation (policies, SOPs and forms).
• Manage preparation, review and approval of policies, SOPs and forms, ensuring regulatory and Trust requirements are included.
• Manage documentation control of SOPs and forms and the biennial review process for SOPs.
• Ensure SOPs and forms are published in the correct format and location.

CAPA, Training and Vendor Management

• Identify and report incidents requiring corrective and preventative actions to the Quality Assurance Manager.
• Collaborate with the R&I Workforce Development Team to ensure an appropriate training matrix for all R&I staff and track compliance.
• Oversee training on policies, SOPs, templates and other documentation for R&I staff and researchers, ensuring documentation of training events.
• Provide training metrics for quarterly HRGQI reporting; manage retention of staff training records per Trust policy.
• Support NUH researchers on ICH-GCP principles and compliance; assist in preparing and delivering targeted training programs on ICH-GCP, governance and quality management to relevant departments.
• Oversee the R&I Approved Vendor system; assess vendors, approve or reject based on due diligence, and review vendors per SOPs.

Inspections and Monitoring

• Collaborate with HRGQI and senior management to prepare for local inspections and provide support during inspections.
• Assist in responding to inspection findings and coordinating CAPAs.
• Develop and deliver a risk-based monitoring programme for research and pharmacovigilance to ensure ongoing compliance with protocols, ICH-GCP, regulatory requirements and NUH SOPs.
• Review risk assessments and monitoring plans; ensure risk-based monitoring and actioned responses to any failures.
• Coordinate monitoring activities with research teams, including source data verification, consent processes, pharmacovigilance and accountability for IMPs/devices/equipment/clinical samples.
• Ensure monitoring reports are completed, findings disseminated, and overdue monitoring visits escalated as needed.
• Assist in preparing complex reports for QC oversight committees.

This list is not exhaustive; the post holder may undertake other duties appropriate to the grade.