Senior Quality Manager

Job responsibilities

1.0 Quality Management

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 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 manner3.3 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.

5.0 Education and Training

5.1 Provide specialist advice and resource for internal and external partners.5.2 In collaboration with senior staff, develop and implement a rolling programme of core training in relation to specific departmental SOPs, especially with regard to regulatory compliance requirements and governance standards.5.3 Coordinate mock inspections as learning tools within the directorate as necessary, to maintain a state of readiness for regulatory inspection.5.4 Seek exemplars from other organisations and share information and learning with the wider organisation.

6.0 Personal/ Professional Development

6.1 Ensure own professional knowledge is regularly updated and keep abreast of relevant developments, making effective use of learning opportunities and actively promoting the workplace as a learning environment.6.2 Maintaining and developing knowledge of national and local clinical and research quality initiatives.6.3 Participate in personal objective setting and review, including the creation of a personal development plan.6.4 Actively seek mentorship/supervision/coaching to enable reflection and own personal development within the role.6.5 Adhere to professional Codes of Conduct if applicable6.6 Adhere to the standards laid down in the NHS code of conduct for manager.

Qualifications

Essential

• Educated to post-graduate degree level
• Evidence of continuing professional development.

Desirable

• Master's degree
• Evidence of Continuing Professional Development

Experience

Essential

• Previous experience in haematology quality management
• Experience of writing Quality System policies and procedures
• Demonstrable success in working with complex organisation

Desirable

• Experience of risk management, incident investigation or performance improvement. Training in QI methodologies such as lean or Six Sigma
• Training in QI methodologies such as lean or Six Sigma
• Understanding of stem cell transplantation and clinical Haematology

Skills

Essential

• Ability to assess and interpret complicated and conflicting information and use judgement where appropriate
• Excellent verbal, written and presentation skills
• Ability to write and present complex reports and to critically analyse and communicate ideas in complex situations
• Good organisational and time management skills
• Ability to influence and negotiate others in a challenging environment
• Build constructive relationships with internal and external stakeholders including clinicians and managers.
• IT, information, project and time management skills

Desirable

• Experience of developing strategies, policies and business plans

Knowledge

Essential

• Comprehensive knowledge and understanding of standards and legislation that govern transplant practice in the NHS and processes.
• Comprehensive knowledge of Quality Systems
• Knowledge of quality and safety standards, clinical governance and NHS regulatory frameworks
• An Understanding of the principles of management and JACIE accreditation process

Desirable

• Experience of risk management Understanding of stem cell transplantation and clinical haematology

Values

Essential

• Ability to demonstrate the organisational values and behaviours

Other

Essential

• Professional, approachable and collaborative.
• Able to work and act independently
• Strong Personal integrity
• Innovative and positive approach
• Flexible and able to work with a multidisciplinary team.
• High level of emotional intelligence
• Commitment to continuous improvement and high standards of care

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.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).