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
The post holder will 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, tracks CAPAs, and supports investigations to ensure actions are implemented and lessons learned.Maintains accurate records, produces reports, and helps analyse data to drive improvements.Works across teams to ensure compliance (including GCP) and promote best practice. Also delivers training and supports continuous system and process improvement.
About us
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, but as a national specialist around 15% patients are referred to us 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 every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
Job 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.
- Contributing to the development of the QMS, with a focus on electronic solutions; such as QMS to streamline quality workstreams and CAPA management.
- Support/lead as required on administration of R&I incident investigation and management, ensuring learning is shared and actions followed up appropriately.
- Provide support in the preparation, facilitation of external audits /inspections/accreditation visit conducted within the programme.
- CAPAs tracking and completion of actions following incidents, audits, changes in practice etc.
- To assist teams in the review of documents and completion of 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.
- Requiring sensitive negotiation where necessary to ensure improvements are built into service delivery and are demonstrated in clinical outcomes.
- To 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 Divisional and Trusts quality agenda in promoting a culture of continuous improvement.
- In collaboration with the Research Quality and Regulatory Compliance Manager 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 the 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 that are 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 to the effectiveness of the Quality Management System and to contribute to validation exercises of new computerised systems in use within R&I setting.
- Ensure that all paper-based/electronic systems are maintained securely.
Continuing Professional Development and Education
- Take responsibility for self-development through the appraisal system and work towards completing agreed personal development plan
- Develop new skills and knowledge pertaining to the speciality as required and attend relevant training / 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) (Amendment) Regulations and UK Data privacy legislation.
- Provide training to staff in the use electronic quality management systems/ 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/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 willing to challenge traditional assumptions and provide 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.
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.
Research Quality and Regulatory Compliance Manager
£32,073 to £39,043 a yearPro rata Per Annum
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