We are seeking a highly motivated and proactive Quality Assurance Officer to join the Research Quality and Regulatory Compliance Team within the Research & Innovation Division at The Christie NHS Foundation Trust.
This is an exciting opportunity to play a key role in supporting and maintaining the Research & Innovation Quality Management System (QMS), ensuring compliance with regulatory requirements and promoting a culture of continuous improvement.
You will work closely with operational and clinical teams to support quality assurance activities across the Trust’s research portfolio. The role requires strong organisational, analytical and communication skills, alongside the ability to manage competing priorities and work collaboratively with a wide range of stakeholders. You will contribute to audit activity, incident management, reporting processes and quality improvement initiatives, helping to ensure research is delivered safely, effectively and to the highest standards.
Main duties of the job
- Support day‑to‑day management of the Research & Innovation Quality Management System, including document control, audits, incidents and change control.
- Assist with audits and inspections, track CAPAs, and support investigations to ensure actions are implemented and lessons learned.
- Maintain accurate records, produce reports and analyse data to drive improvements.
- Work across teams to ensure compliance (including GCP) and promote best practice.
- Deliver training and support continuous system and process improvement.
Working for our organisation
The Christie is one of Europe’s leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, and a national specialist service that receives around 15% of patients referred from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world‑first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials a year; cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
Detailed job description and main responsibilities
Quality Management and Improvement
- Conduct the day‑to‑day management of the QMS modules including document management, audit management, change management and asset management.
- Contribute to the development of the QMS, with a focus on electronic solutions such as QMS to streamline quality workstreams and CAPA management.
- Support/lead administration of R&I incident investigation and management, ensuring learning is shared and actions followed up appropriately.
- Provide support in the preparation and facilitation of external audits, inspections and accreditation visits within the programme.
- Track CAPAs and complete actions following incidents, audits and changes in practice.
- Assist teams in reviewing documents and completing audits as required by regulatory standards.
- Prepare documents and agendas for governance and operational meetings.
- Communicate with a wide range of internal and external stakeholders regarding quality improvement.
- Negotiate sensitively where necessary to ensure improvements are built into service delivery and demonstrated in clinical outcomes.
- Attend regular and ad‑hoc meetings as required.
- Contribute to the development of quality improvement plans and lead on quality improvement audits/projects as required.
- Work collaboratively with the Research Quality and Regulatory Compliance Manager to assist with the identification and meeting of quality objectives as set out by the annual quality report.
- Contribute to the Divisional and Trust’s quality agenda in promoting a culture of continuous improvement.
- Recognise and act upon departures from legislative, quality management system requirements including failure to follow protocols and/or SOPs and incidents, errors or adverse events, responding appropriately and escalating action as required.
- Work in accordance with Divisional standards for document control and change control, providing support for the operational implementation of such processes as required.
Information Management
- Maintain precise and accurate quality management records ready for inspection by regulatory authorities, accreditation bodies and Sponsor.
- Provide regular and ad‑hoc reports as required.
- Assist in ensuring that business continuity arrangements are in place and updated in the event of any disruptions to electronic systems.
- Update and maintain databases relating to the Quality Management Framework.
- Interact with Trust reporting systems – DCIQ – and other relevant reporting systems to evaluate quality findings.
- Support the Research Quality and Regulatory Compliance Manager in the analysis of intelligence to assess the effectiveness of the Quality Management System and to contribute to validation exercises of new computerised systems in use within the R&I setting.
- Ensure that all paper‑based and electronic systems are maintained securely.
Continuing Professional Development and Education
- Take responsibility for self‑development through the appraisal system and work towards completing an agreed personal development plan.
- Develop new skills and knowledge pertaining to the speciality as required and attend relevant training and study days.
- Maintain and update knowledge of related regulatory and other relevant standards including ICH‑GCP, UK Policy Framework for Health and Social Care Research, Medicines for Human Use (Clinical Trials) Regulations and UK Data privacy legislation.
- Provide training to staff in the use of electronic quality management systems and control systems software applications.
Person specification
Qualifications
- Educated to degree level or equivalent specialised professional knowledge.
- Evidence of continuing professional development.
- Current GCP Certificate.
Experience
- Previous experience of audit and follow‑up actions.
- Experience of collating, using, analysing and presenting data.
- Experience of working with incident/issue management framework.
- Quality Improvement experience.
Skills
- Able to problem solve and initiate change.
- Able to work across professional teams and organisational boundaries.
- Good organisational skills with the ability to problem solve and negotiate.
- Ability to prioritise against tight deadlines.
- Excellent verbal, reporting and presentation skills.
- Good interpersonal and communication skills, with the ability to establish and maintain effective working relationships.
- Able to influence, even within a complex and challenging environment.
- Ability to provide reasoned advice and support.
- Ability to evaluate evidence and make reasoned independent decisions.
- Demonstrable ability to develop and maintain effective partnership arrangements both internal and external to the service.
Knowledge
- An understanding of the principles of quality management systems.
- Knowledge of clinical research standards and regulations.
- Human Tissue Standards.
Values
- Ability to demonstrate the organisational values and behaviours.
Other
- A flexible approach to work.
- Willing to support others.
- Effective time management.
- Confident in challenging traditional assumptions and providing evidence to support change and drive forward improved ways of working.
- Takes responsibility for own actions and promotes good team working.
- Shares information and good practice appropriately.
We welcome and encourage applications from people of all backgrounds, including Black, Asian and other ethnic minority communities, people with disabilities and underrepresented groups. Appointment will be based on merit and we are committed to creating a balanced and diverse workforce. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.
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