Job summary
The ideal candidate will have extensive experience of Quality Management within a HFEA licensed clinic setting. Whilst we are looking for someone to drive forward laboratory accreditation to ISO15189 standard, there is also a primary requirement to ensure compliance with the HFEA regulatory requirements.
The quality management standards required by the HFEA are closely aligned with UKAS standards, although they cover both the clinical and the laboratory service.
Exact hours/days of work can be negotiated.
NUH Life Fertility Service is a small but dedicated multidisciplinary team of Clinicians, Nurses, Healthcare Scientists and Administration Staff providing fertility care to both men and women in the East Midlands region. Having recently undergone a large investment in our service, we now have an exciting opportunity for a Quality Manager to join our team, located in new and purpose built facilities
Main duties of the job
In addition to the below summary you need to familiarise yourself with the full Job Description and Person Specification documents attached to this advert.
The Quality Manager is a key member of the Senior Management Team, and as such is responsible for developing and maintaining a robust Quality Management system, ensuring that the unit adheres to a Quality Policy and maintains high standards of patient care. They will work closely with the Andrology Service Lead, HFEA PR and Nurse Manager to ensure a high standard of patient care, and a culture of continual improvement.
The successful post holder will be required to co-ordinate quality related activities, hold departmental Quality Meetings, and delegate specific tasks to both senior managers (medical, nursing and scientific) and other more junior staff within the unit. The post holder will take a lead on preparing the laboratory service to achieve the international accreditation standard ISO15189. The post holder will need to be an effective communicator in liaising with regulators and other inspectorates and be able to delegate tasks in order to meet external deadlines. The person should have a background in laboratory medicine and detailed knowledge of laboratory accreditation systems, alongside a good understanding of the HFEA Code of Practice.
About us
With over 17,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation.
Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at NUH we will endeavour to turn your job into a career!
We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH.
Job description
Job responsibilities
Responsible for developing and maintaining the quality management system and ensure compliance with the relevant standards from regulators and external inspectorates.
Work closely with senior staff to ensure that the units facilities, staffing, procedures and continuous evaluation system complies with regulation, particularly those relating to the HFEA, European Union Cells and Tissues directive (EUTD) and relevant UKAS standards
Undertake a gap analysis against current UKAS laboratory accreditation standards, and support the Andrology Service Lead in developing an achievable timetable for gaining ISO15189 accreditation.
Represent the department with reference to Quality Management issues at trust-wide meetings and meetings with external organisations.
Take a lead in the establishment, implementation and development of the quality management system. Ensure that all fertility unit activities (laboratory and clinical) are appropriately described within operating procedures, results of those activities are recorded on suitable laboratory and clinic forms and that all of those procedures and forms meet the required standards for document control.
Liaise with external inspectorates (HFEA and UKAS) where appropriate and act as a lead representative during formal assessments.
Conduct an AMR (Annual Management Review) with the service and clinical leads and assist in the production of a written report with clear and measurable objectives.
Job description
Job responsibilities
Responsible for developing and maintaining the quality management system and ensure compliance with the relevant standards from regulators and external inspectorates.
Work closely with senior staff to ensure that the units facilities, staffing, procedures and continuous evaluation system complies with regulation, particularly those relating to the HFEA, European Union Cells and Tissues directive (EUTD) and relevant UKAS standards
Undertake a gap analysis against current UKAS laboratory accreditation standards, and support the Andrology Service Lead in developing an achievable timetable for gaining ISO15189 accreditation.
Represent the department with reference to Quality Management issues at trust-wide meetings and meetings with external organisations.
Take a lead in the establishment, implementation and development of the quality management system. Ensure that all fertility unit activities (laboratory and clinical) are appropriately described within operating procedures, results of those activities are recorded on suitable laboratory and clinic forms and that all of those procedures and forms meet the required standards for document control.
Liaise with external inspectorates (HFEA and UKAS) where appropriate and act as a lead representative during formal assessments.
Conduct an AMR (Annual Management Review) with the service and clinical leads and assist in the production of a written report with clear and measurable objectives.
Person Specification
Training and Qualifications
Essential
- BSc Degree in a Life Science
- Evidence of relevant CPD
Desirable
- Evidence of formal qualification/training in Quality Management
Experience
Essential
- At least 3yrs experience in a senior scientific post or Quality Management role within a HFEA licensed fertility centre
- Experience of laboratory accreditation and all aspects of a total quality management system
- Experience of gaining and maintaining UKAS laboratory accreditation to ISO15189 standard
- Staff management experience and highly developed people skills, with a track record of engaging staff in QM workflows
Communication and Relationship Skills
Essential
- Excellent relationship skills, using empathy and persuasive communication techniques to ensure whole team input into the QMS
- Ability to present complex information in clear and concise written and verbal reports
Desirable
- Lecturing/teaching experience
- Experience of chairing meetings
Analytical and Judgement Skills
Essential
- Understanding of the principles of Audit and Risk Management
- A broad knowledge/understanding of clinical and laboratory regulation and governance processes
Desirable
- Knowledge of the medical, scientific and regulatory processes associated with a fertility unit including HFEA and the EUTD (EU cells and tissues directive)
Planning and Organisation Skills
Essential
- Able to carry out long term strategic planning to ensure adequate quality systems and continual improvement
- Ability to organise and schedule an evaluation system which includes audit of all areas of practice and plan corrective and preventative action where required
Commitment to Trust Values and Behaviours
Essential
- Experience of and understanding of patient centred care in a reproductive healthcare setting
Other requirements specific to the role
Essential
- Willingness to work flexibly in the run up to and during inspections
Person Specification
Training and Qualifications
Essential
- BSc Degree in a Life Science
- Evidence of relevant CPD
Desirable
- Evidence of formal qualification/training in Quality Management
Experience
Essential
- At least 3yrs experience in a senior scientific post or Quality Management role within a HFEA licensed fertility centre
- Experience of laboratory accreditation and all aspects of a total quality management system
- Experience of gaining and maintaining UKAS laboratory accreditation to ISO15189 standard
- Staff management experience and highly developed people skills, with a track record of engaging staff in QM workflows
Communication and Relationship Skills
Essential
- Excellent relationship skills, using empathy and persuasive communication techniques to ensure whole team input into the QMS
- Ability to present complex information in clear and concise written and verbal reports
Desirable
- Lecturing/teaching experience
- Experience of chairing meetings
Analytical and Judgement Skills
Essential
- Understanding of the principles of Audit and Risk Management
- A broad knowledge/understanding of clinical and laboratory regulation and governance processes
Desirable
- Knowledge of the medical, scientific and regulatory processes associated with a fertility unit including HFEA and the EUTD (EU cells and tissues directive)
Planning and Organisation Skills
Essential
- Able to carry out long term strategic planning to ensure adequate quality systems and continual improvement
- Ability to organise and schedule an evaluation system which includes audit of all areas of practice and plan corrective and preventative action where required
Commitment to Trust Values and Behaviours
Essential
- Experience of and understanding of patient centred care in a reproductive healthcare setting
Other requirements specific to the role
Essential
- Willingness to work flexibly in the run up to and during inspections
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.
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).
Additional information
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.
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).