Job Description Job Title: Location: Blood Transfusion Compliance Lead 60 Whitfield Street Laboratories, London Reporting to: Clinically: Consultant Haematologist Managerially: Director of Quality and Laboratory Operations Managers Accountable to: TDL Medical Director Overall Job Purpose: To define and deliver a compliance framework, within the Quality Management System, for Blood Transfusion (BT) related activities in accordance with appropriate accreditation or regulatory bodies (e.g. CPA, GXP etc.). Main Duties: To include, but not be restricted to, the following duties: 1. To lead TDL, as an organisation, in the definition and implementation of a compliance framework covering the Blood Transfusion related activities. 2. To report to Laboratory management on the functioning and effectiveness of the compliance aspects of Blood Transfusion related activities across the organisation. 3. To provide a compliance lead and point of initial contact for quality guidance on the day to day activities concerning Blood Transfusion across the network. 4. To assist with the establishment and documentation of quality manuals, quality policies and objectives, including formulating a plan for ensuring these are in place and in use for BT activities in addition to other activities. 5. To assist QMG in ensuring that the Quality Management System functions correctly, by managing and maintaining quality monitoring systems commensurate with establishing safe and effective Blood Transfusion service provision across the organisation. 6. To assist QMG in ensuring that the Quality Management System functions correctly by helping the Director to develop, manage and maintain regular BT quality meetings with key stakeholders both internally and external to the TDL organisation. Title: BT Compliance Lead Job Description Pages: Page 1 of 4
7. To assist QMG in ensuring that the Quality Management System functions correctly by driving the development and implementation of an effective and efficient auditing programme which incorporates all BT activities across the organisation. 8. To participate in the management review process for the Quality Management System. 9. Assisting the Director of Quality with the monitoring of, External Quality Assessment schemes for Blood Transfusion 10. To drive the standardisation and continuous improvement of TDL Blood Transfusion process and services where possible 11. To ensure all quality procedures are performed in accordance with the relevant Health and Safety legislation 12. To participate in annual joint review 13. To liaise and assist the operational lead for BT in ensuring projects follow the QM structure General Duties To become familiar with the day to day organisation of the department as it affects your work. You should be aware of the functions of the members of staff in the department as they affect your work. To attend laboratory meetings as required. Work with the BT operational lead to ensure projects follow the quality management system. To undertake such work as you are assigned in a careful and efficient way and in compliance with current CPA standards, regulatory requirements and the TDL Quality Management System. To communicate in a friendly, helpful and non-prejudicial manner in your dealings with staff, clients and / or customers as you will be regarded as a representative of your department as well as the Company, and you should behave accordingly. Matters regarding patients are confidential and must not be discussed except in the course of your duties. You will be expected to sign an undertaking to observe all patient and Company confidentiality. To be aware of and abide by the rules and codes of the department. This is particularly important in the case of Health and Safety and Fire procedures. To behave in a professional manner and cooperate with all other members of staff at all times. You will be trained for the work you are expected to do. Do not attempt any work unless you are confident that you can carry it out properly. To adhere to and to positively promote the Sonic / TDL Core Values. Title: BT Compliance Lead Job Description Pages: Page 2 of 4
To maintain high standards of work within your department. Other duties as assigned by the Director of Quality and the Principal Quality Manager TDL. To participate in an Annual Joint Review. Title: BT Compliance Lead Job Description Pages: Page 3 of 4
Person Specification Attributes Requirements Biological / Biomedical science degree or equivalent. Qualifications Higher specialist diploma and or BBBTS certificate of competence Preference for a post graduate qualification of MSc or equivalent in a relevant discipline Preference for a Quality Management qualification Experience of working within the healthcare field (specifically: experience of working in a Blood Transfusion / Regulatory / QA environment). Experience Knowledge and application of CPA, MHRA standards and Blood Directives. Experience of managing regulatory inspections and interactions with the regulators at a managerial level Experience of developing and managing Quality based system audits. Report writing experience. Excellent written and verbal communication skills. Ability to work on own initiative and as part of a team. Skills and Abilities Numerate. Highly skilled in use of Microsoft Office. Experience of utilising statistical analysis software. Able to take minutes and write reports Personal Qualities Flexible, highly motivated, effective team player; methodical, ability to understand and meet targets and deadlines, able to learn and assimilate new information. Commitment to working the hours required to fulfil the job, including flexibility of working. This job description is subject to amendment in response to the changing needs of the department and company requirements. Title: BT Compliance Lead Job Description Pages: Page 4 of 4
This job description will be reviewed as part of the Annual Joint Review. I have read and understood and agree with this job description and confirm that I have been provided with a copy for my own records. Employee: Signed:. Date:. Manager:... Signed:. Date:. Title: BT Compliance Lead Job Description Pages: Page 5 of 4