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 to be the best acute teaching organisation. 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.

Main duties of the job

• 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, including the UK Policy Framework for Health and Social Care for Research, Good Clinical Practice, the Medicines for Human Use (Clinical Trials) Regulations, the Human Tissue Act and the Mental Capacity Act.
• The post holder, based at QMC, will be responsible for promoting and developing a culture that supports high quality research through help and support to research leaders and their teams.
• The post holder will play a key role in the co-ordination of standards, working practices and policy implementation to ensure that NUH and our partners are at all times compliant with both internal policies and external regulatory frameworks.
• The post holder will also play a key role in preparing for external audits and MHRA inspections.

Working for our organisation

With over 19,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation. We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH.

Detailed job description and main responsibilities

GENERAL DUTIES

• Contribute to policy development for NUH.
• The post holder must ensure GCP and R&I SOP training is complete and their training records are up to date.
• Maintain precise and accurate quality management records that are ready for inspection by regulatory bodies and Sponsors on demand.
• Undertake quality control checks of research activity undertaken within and on behalf of NUH, in conduction with our partners, including but not limited to our suppliers, BRC Partners, the CRF and Clinical Trials Unit.
• Document accountability and traceability of Investigational Medicinal Products (IMPs)/study drugs to ensure receipt, storage, dispensing, administration and disposal are in line with local SOPs.
• Recognise and respond to research governance and quality issues that might arise during quality control checks.
• Escalate departures from legislative and research governance requirements, e.g., reporting serious breaches in accordance with regulations.
• Promote a quality culture among NUH and partner researchers.
• Maintain good working relationships with academic and service departments to promote teamwork.
• Record and report incidents to the R&I board and wider research teams as appropriate, ensuring reports are submitted to regulatory authorities.
• Work autonomously and efficiently; maintain effective communication across NUH where non-compliances are identified.
• Ensure Trust reporting systems (including DATIX) are utilised 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 (e.g., monitoring visits, training performance).
• Work in accordance with Trust-wide policies and procedures.
• Assist in information governance or potential fraud and misconduct issues identified through quality control activities or inspection.
• Maintain knowledge of legislation and guidance governing clinical research and quality management processes.

Education and Training

• Maintain knowledge of EU and UK legislation, regulations, management and conduct of research and act as an NUH expert on these matters.
• Maintain personal training record.

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 met.
• Manage documentation control of SOPs and forms and the biennial review process.
• Ensure SOPs and forms are published in the correct format and location.

CAPA Management

• Identify and report incidents requiring corrective and preventative actions to the Quality Assurance Manager.

Training Management

• Collaborate with the R&I Workforce Development Team to ensure an appropriate training matrix for all R&I staff.
• Track training compliance and provide metrics for quarterly reporting.
• Provide support and advice to NUH researchers on ICH-GCP and compliance.
• Assist in delivering targeted training programmes on ICH-GCP, governance, compliance and quality management.

Vendor and Inspections

• Manage the R&I Approved Vendor system and conduct due diligence on vendors.
• Prepare for local inspections and respond to inspection findings with corrective actions.

Monitoring

• Develop and maintain a risk-based monitoring programme for research and pharmacovigilance functions to ensure compliance with ICH-GCP, regulatory requirements and NUH SOPs.
• Review risk assessments and monitoring plans for a risk-based approach.
• Coordinate monitoring activities with research teams and ensure findings are relayed for CAPA where needed.
• Ensure monitoring findings are disseminated to drive continuous improvement.
• Escalate overdue monitoring visits as required.
• Assist in preparing complex reports for QC oversight committees.

This list is not exhaustive; other duties may be required.

Person specification

Commitment to Trust Values and Behaviours

• Demonstrate behaviours consistent with the Trust’s “We are here for you” standards.

Training & Qualifications

• Master’s level or equivalent in a life science or clinical subject preferred.
• Professional knowledge of clinical research with suitable trial coordination or management experience.
• Expert knowledge of GCP, the Human Tissue Act and the Mental Capacity Act.
• Knowledge of data confidentiality and security.
• Evidence of Continuous Personal Development.
• Understanding of ISO14155 and UK Policy Framework for Health and Social Care Research (2017).

Experience

• Experience with trial managers, researchers and department managers.
• Knowledge of the clinical trial lifecycle and quality control in a clinical research environment.
• Experience in risk assessments, monitoring visits, source data verification, and SOP development.
• Experience delivering quality control and training modules.
• Knowledge of NHS research governance and risk-based quality programs.
• Experience of regulatory inspections.

Communication and Relationship Skills

• Strong interpersonal and written/oral communication with diverse audiences.
• Ability to influence and lead in change; build relationships and work across organisations.

Analytical, Judgement and Planning Skills

• Ability to analyse research management information and make complex judgments.
• Strong problem solving and negotiation skills.
• Ability to plan, manage and deliver complex projects, with minimal supervision and good presentation skills.

Physical and Other Requirements

• Ability to travel across campuses and nationally for audits and meetings; full driving licence and vehicle access.

Closing dates and application guidance:

Please submit your application promptly; NUH reserves the right to close vacancies earlier than the published closing date if needed. All applicants should check email regularly. Applicants are advised to refrain from using AI at any stage during the recruitment process. We are an equal opportunities employer and welcome applications from diverse communities.