Address
SalaryThe successful candidate will be highly motivated and driven by being responsible for assuring the quality of all areas of clinical practice within Haematology against the current standards, including international standards. This will include delivery and oversight of quality improvement programmes. Excellent knowledge of quality management and experience is essential to ensuring that changes and processes are fit for purpose and in line with the needs of patients, the team, and the organisation. The post holder will also be risk lead for the directorate and will manage risks within the service.
The post-holder will have well developed organisational skills, be an excellent communicator (written and oral), be used to managing and delivering to deadlines and have strong analytical skills. Excellent interpersonal skills are paramount for this post together with confidence to engage and work with a range of colleagues at all levels and from all professional groups.
- international legislation and regulations and ensuring that haematology policies and procedures include the relevant current regulatory/ legal guidance.
- Work in collaboration with senior team members to ensure systems to ensure the quality and conduct of haematology and transplant activity is integrated and is aligned with any internal and relevant external organisation systems and practices
- Be responsible for the development and implementation of a Quality Assurance (QA) strategy and quality improvement programme (QIP) in conjunction with the improvement and operational manager in order to ensure that the department maintains a system of continuous quality improvement that meets the requirements of evolving legislation
- Provide specialised QA and regulatory advice and support to the operational teams, on the application of and adherence to quality processes, this will include interpreting the different requirements of each party and differing highly complex legislation. Providing a coherent unified respons
- Responsible for the development, implementation and maintenance of a document management system, ensuring policies, Standard Operating Procedures (SOPs) are updated and controlled according to regulatory requirements; including: ensuring SOPs are current, appropriately tracked with version control, authorised and available for audit/ inspection as appropriate and are effectively communicate
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.
- Develop, implement and monitor systems to ensure regulatory compliance with JACIE and other relevant regulatory bodies, developing QA procedures to support the clinical practice. Be responsible for the development and implementation of the risk programme in conjunction with the senior management team
- Lead in the planning of specified internal programmes for system review/ audit. Initiate, develop and evaluate action plans and make recommendation for adjustment to agreed programmes based on emerging risk/quality intelligence sources
- Responsible for the organisation and conduct of mock inspections within the clinical areas, in order to check that services and staff are prepared for regulatory inspection and that individual staff members are aware of their research governance responsibilities. Host external audits and inspections within haematology and the directorate providing support to other areas as necessary
- In collaboration with the transplant director, lead the preparation for mandatory regulatory inspections (e.g. JACIE).
- Responsible for the coordination and liaison with regulatory agencies during mandatory inspections, accompanying the inspectors, responding promptly to requests for information and ensuring that designated staff are available for interview as required
- To be risk lead for the directorate. To liaise with senior managers within the directorate to produce a specific Risk Registe
- Provide guidance on incident management to all relevant staff as necessary, ensuring incidents are investigated appropriately and in a timely manner
- The post holder will be the lead quality specialist within haematology, and as such will have significant discretion and freedom to act within the confines of local, national and international accepted standards
- The post holder will develop, implement and maintain appropriate quality systems, policies and standard operating procedures to assure that the quality and compliance of practice in relation to JACIE, CQC, HTA and other relevant regularity bodies. This will involve the interpretation of current and emerging complex nationa
- In conjunction with the clinical services manager lead on the investigation into grade 3 + and serious incidents ensuring accurate record of events and high-quality action plans are developed in a timely manner and improvements to process, policy and practice take place. Ensure the director is fully compliant with the duty of candour requirements
- Responsible for co-ordinating complaints and concerns in conjunction with the PALS team
- Line management responsibilities for quality staff within the directorate including recruitment and selection and appraisals.
1.1 The post holder will be the lead quality specialist within haematology, and as such will have significant discretion and freedom to act within the confines of local, national and international accepted standards.
1.2 To develop, implement and maintain appropriate quality systems, policies and standard operating procedures to assure that the quality and compliance of practice in relation to JACIE, CQC, HTA and other relevant regularity bodies. . This will involve the interpretation of current and emerging complex national and international legislation and regulations and ensuring that haematology policies and procedures include the relevant current regulatory/ legal guidance.
1.3 Work in collaboration with senior team members to ensure systems to ensure the quality and conduct of haematology and transplant activity is integrated and is aligned with any internal and relevant external organisation systems and practices.
1.4 Responsible for the development and implementation of a Quality Assurance (QA) strategy and quality improvement programme (QIP) in conjunction with the improvement and operational manager in order to ensure that the department maintains a system of continuous quality improvement that meets the requirements of evolving legislation.
1.5 Provide specialised QA and regulatory advice and support to the operational teams, on the application of and adherence to quality processes, this will include interpreting the different requirements of each party and differing highly complex legislation. Providing a coherent unified response.
1.6 Responsible for the development, implementation and maintenance of a document management system, ensuring policies, Standard Operating Procedures (SOPs) are updated and controlled according to regulatory requirements; including: ensuring SOPs are current, appropriately tracked with version control, authorised and available for audit/ inspection as appropriate and are effectively communicated.
1.7 The post holder will also have line management responsibilities and be a delegated budget holder for the improvements and operations manager.
1.8 The post holder will be a leading member of the quality management group including deputising as Chair for the Transplant Director when required.
2.0 Assurance and Compliance
2.1 Develop, implement and monitor systems to ensure regulatory compliance with JACIE and other relevant regulatory bodies, developing QA procedures to support the clinical practice. Be responsible for the development and implementation of the risk programme in conjunction with the senior management team.
2.2 Lead in the planning of specified internal programmes for system review/ audit. Initiate, develop and evaluate action plans and make recommendation for adjustment to agreed programmes based on emerging risk/quality intelligence sources.
2.3 Responsible for the organisation and conduct of mock inspections within the clinical areas, in order to check that services and staff are prepared for regulatory inspection and that individual staff members are aware of their research governance responsibilities. Host external audits and inspections within haematology and the directorate providing support to other areas as necessary.
2.4 In collaboration with the transplant director, lead the preparation for mandatory regulatory inspections (e.g. JACIE).
2.5 Responsible for the coordination and liaison with regulatory agencies during mandatory inspections, accompanying the inspectors, responding promptly to requests for information and ensuring that designated staff are available for interview as required.
2.6 Responsible for implementation of any inspection findings, taking responsibility for coordinating remedial action, ensuring completion of tasks and attainment of requisite regulatory standards.
2.7 Report on the outcome of quality system audit / reviews, ensuring there is appropriate escalation where necessary.
2.8 Work with stakeholders to scrutinise and provide expert advice and guidance on remedial, corrective and preventive actions (CAPA) in response to incidents, audit, inspection and monitoring findings. Facilitate the assessment of root causes to prevent reoccurrence.
2.9 Support the clinical teams to deliver significant improvements in patient care for the directorate.
2.10 Examine data systematically through ongoing monitoring, evaluation and improvement activities.
2.11 Monitor patient satisfaction on an on-going basis through the formulation of patient surveys.
2.12 Undertake validation studies on significant processes and/or equipment used in the transplant programme, present findings and recommendations.
3.0 Risk Management, incident investigation and complaints management
3.1 To be risk lead for the directorate. To liaise with senior managers within the directorate to produce a specific Risk Register.
3.2 Provide guidance on incident management to all relevant staff as necessary, ensuring incidents are investigated appropriately and in a timely manner
3.3 In conjunction with the clinical services manager lead on the investigation into grade 3 + and serious incidents ensuring accurate record of events and high quality action plans are developed in a timely manner and improvements to process, policy and practice take place. Ensure the director is fully compliant with the duty of candour requirements.
3.4 In conjunction with the clinical services manager and clinical director foster a culture of reporting and investigating incidents as per trust policy.
3.5 Responsible for co-ordinating complaints and concerns in conjunction with the PALS team.
4.0 Managerial
4.1 Line management responsibilities for quality staff within the directorate including recruitment and selection and appraisals.
4.2 Provide a presence in all areas involved in quality improvement and deploy communication, engagement and influencing skills to convey complex and potentially contentious information to a variety of stakeholders in both formal and informal settings.
4.3 External and internal representation of the directorate in specialist forums or consultative groups relating to quality, risk and compliance.
4.4 Develop and deliver a sustainable culture and environment that promotes effective collaboration and the achievement of continuous improvement by maintaining commitment to the goals and aims of the quality strategy and quality objectives.
4.5 Maintain a range of communication resources to ensure all staff has access to up to date information about quality improvement initiatives and outcome.
