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Pathology Quality and Compliance Manager

companyUniversity Hospitals Sussex NHS Foundation Trust (279)
locationBrighton and Hove, UK
PublishedPublished: Published yesterday
Business Compliance
Job summary

The Pathology Quality Manager (PQM) will report into the Pathology Head of Quality & Compliance and will be a key member of the Pathology Management Team. The post holder will be empowered to lead on the design & implementation of the quality & governance systems for pathology services across the Trust. The PQM is responsible for the continuing development, implementation, maintenance & improvement of the quality management system across UH Sussex pathology service, working in conjunction with the departmental lead biomedical scientists, chief biomedical scientists, support area managers & departmental clinical leads to ensure that the quality management system implemented is robust & operationally effective. The post holder ensures designated areas in pathology services have quality management & governance systems in place that will achieve & maintain the required standards for the quality aspects of regulatory controls including the Medicines & Healthcare products Regulatory Agency (MHRA), Human Tissue Authority (HTA) & the United Kingdom Accreditation Service (UKAS). The PQM works with and supports the Head of Quality and Compliance, Compliance Manager - Blood Transfusion, Environment Health and Safety Lead, biomedical scientists and consultants in resolving any issues that involve the completion of quality and governance actions to address any areas of concern.

Main duties of the job

Investigate problems with efficiency & suitability using audit data analysis & trends, ensuring quality information is disseminated throughout the department. Provide complex information to the Pathology Management Team; including preparation for & outcomes of accreditation/regulatory visits, complaints & plaudits, & reviews of findings from investigations into incidents & complaints.Present formal/informal discussions on quality as well as present/review complex audit data.Use judgement to identify areas and particular projects where there is the potential for improvement in quality to the benefit of the service provided by the laboratories. Analyse & review the effectiveness of the Pathology quality management systems. Analyse reports from external assessments/inspections & verify the completion of corrective actions.Management of Pathology risks & their update as per risk review processes.Manage verification, validation & implementation of new processes & equipment in accordance with national (Better Blood Transfusion) guidelines issued by the Department of Health, MHRA & ISO15189 standards. Deputise for the Head of Quality & Compliance as required. Attend quality meetings with the Head of Quality and DQSL to discuss quality progress. Oversight of quality actions from incident investigations, complaint responses & local audit outcomes.In conjunction with the Head of Quality, manage the quality activities of departmental quality officers & management teams.

About us

At UHSussex, diversity is our strength, and we want you to feel included to help us always put the Patient First. Your uniqueness and experiences will be part of our creative and innovative community where everyone is encouraged to succeed. We have a range of Staff Networks to help break down barriers, and can offer a buddy to help new members settle in. We're proud to be a Disability Confident Employer (Level 2) and a Veteran Aware Trust.

We treat our patients and staff with the same compassion and empathy we expect for ourselves. We're here for them when they need us, and we go above and beyond to meet their needs. This can be seen in ourWellbeing Programme for staff which is extensive and designed to support you when you need it, including where possible, flexible working to support work life balance - because we know that to look after others we must first look after ourselves.

As a university trust and a leader in healthcare research, we value learning, teaching and training so that we can be the best that we can be. From the moment you start with us and throughout your career we will help you to grow and develop. We hope that in choosing UHSussex you are choosing a long and happy career where you will be able to see the difference you make and feel valued for all that you do.

We look forward to receiving your application and the start of your journey with UHSussex.

Candidate Information Pack: https://www.uhsussex.nhs.uk/resources/candidate-information-pack/

Job description

Job responsibilities

Please see the detailed job description and person specification that has been included within this vacancy

Job description
Job responsibilities

Please see the detailed job description and person specification that has been included within this vacancy

Person Specification

Professional Registration

Essential

  • Registered with the Health and Care Professions Council (HCPC)
Experience/Qualifications

Essential

  • BSc (Hons) Biomedical Science or equivalent MSc Biomedical Science (or equivalent) Post-graduate qualification in Quality Management (e.g. IBMS Certificate of Extended Practice in Quality Management) Extensive practical experience of biomedical procedures in a relevant discipline; gained through working in an NHS environment of equivalent Extensive experience of Quality Management systems Extensive experience of accreditation and regulatory processes (e.g. CPA/UKAS; MHRA; HTA) Experience in writing standard operating procedures, guidelines and instructions for a clinical laboratory Experience of managing/supervising and training of Biomedical Scientist staff and students Previous experience of leading on laboratory accreditation assessment visits and regulatory inspections. Significant experience required in Incident investigation, root cause analysis and CAPA management Experience in interpreting International and/or National Standards or guidance for translation into local procedures Extensive auditing experience
Desirable

  • Knowledge of current pathology accreditation standards
Skills

Essential

  • Evidence of having undertaken own development to improve understanding of equalities issues Able to negotiate effectively with senior staff Excellent written and verbal communication skills Numerate; Handling data and information analysis Excellent interpersonal skills - able to form effective working relationships at all levels Effective presentation skills - able to present complex information to a general audience Ability to develop and motivate staff Able to work to tight deadlines Ability to prioritise work and to adapt to changing circumstances Excellent I.T. skills, able to use a variety of software packages to analyse and present data and generate reports (e.g. Microsoft Word, Excel and PowerPoint) Extensive knowledge and use of QMS/Compliance software
People Management and Development

Essential

  • Evidence of continuing professional Development Working within senior quality team and overseeing a team of individuals where there are conflicting demands on resources
Freedom to Act

Essential

  • Can support development of multi - departmental policies and strategy. Can create/amend/review standard operating procedures and policies which may in turn be based upon government and national/local policy guidelines that require interpretation. Accountable for own actions and those of subordinates.
Equality Diversity and Inclusion

Essential

  • Evidence of having undertaken own development to improve understanding of equalities issues
  • Evidence of having championed diversity in previous roles (as appropriate to role).
Person Specification
Professional Registration

Essential

  • Registered with the Health and Care Professions Council (HCPC)
Experience/Qualifications

Essential

  • BSc (Hons) Biomedical Science or equivalent MSc Biomedical Science (or equivalent) Post-graduate qualification in Quality Management (e.g. IBMS Certificate of Extended Practice in Quality Management) Extensive practical experience of biomedical procedures in a relevant discipline; gained through working in an NHS environment of equivalent Extensive experience of Quality Management systems Extensive experience of accreditation and regulatory processes (e.g. CPA/UKAS; MHRA; HTA) Experience in writing standard operating procedures, guidelines and instructions for a clinical laboratory Experience of managing/supervising and training of Biomedical Scientist staff and students Previous experience of leading on laboratory accreditation assessment visits and regulatory inspections. Significant experience required in Incident investigation, root cause analysis and CAPA management Experience in interpreting International and/or National Standards or guidance for translation into local procedures Extensive auditing experience
Desirable

  • Knowledge of current pathology accreditation standards
Skills

Essential

  • Evidence of having undertaken own development to improve understanding of equalities issues Able to negotiate effectively with senior staff Excellent written and verbal communication skills Numerate; Handling data and information analysis Excellent interpersonal skills - able to form effective working relationships at all levels Effective presentation skills - able to present complex information to a general audience Ability to develop and motivate staff Able to work to tight deadlines Ability to prioritise work and to adapt to changing circumstances Excellent I.T. skills, able to use a variety of software packages to analyse and present data and generate reports (e.g. Microsoft Word, Excel and PowerPoint) Extensive knowledge and use of QMS/Compliance software
People Management and Development

Essential

  • Evidence of continuing professional Development Working within senior quality team and overseeing a team of individuals where there are conflicting demands on resources
Freedom to Act

Essential

  • Can support development of multi - departmental policies and strategy. Can create/amend/review standard operating procedures and policies which may in turn be based upon government and national/local policy guidelines that require interpretation. Accountable for own actions and those of subordinates.
Equality Diversity and Inclusion

Essential

  • Evidence of having undertaken own development to improve understanding of equalities issues
  • Evidence of having championed diversity in previous roles (as appropriate to role).
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 .

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. .
UK Registration

Applicants must have current UK professional registration. For further information please see

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.
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 .

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. .
UK Registration

Applicants must have current UK professional registration. For further information please see

Employer details

Employer name

University Hospitals Sussex NHS Foundation Trust (279)
Address

Cross Site- UH Sussex Pathology Sites

Royal Sussex County Hospital, Eastern Road

Brighton

BN2 5BE

Employer's website