Job summary
The Leslie Brent Laboratory, based at Hammersmith Hospital within Imperial College Healthcare NHS Trust, is a UKAS-accredited facility (Reg. No. 9280) specialising in Therapeutic Drug Monitoring (TDM). Operating within the Division of Medicine & Integrated Care, the laboratory supports the Renal & Transplant Directorate in general nephrology and a kidney and /or pancreas transplant programme.
Using LC-MS/MS technology, the laboratory delivers precise monitoring of immunosuppressive, immunomodulatory, and antifungal drugs. In addition to renal services, it supports adult and paediatric bone marrow and adult liver transplant programmes.
The department is seeking an experienced and motivated Quality Manager with strong knowledge of ISO15189:2022 and UKAS accreditation. The post holder will play a key role in maintaining compliance, leading audits, managing nonconformances, and driving continuous quality improvement.
Main duties of the job
- Ensure the QMS is fully embedded within laboratory operations, meeting ISO15189:2022 standards and supporting departmental objectives.
- Effectively manage and prioritise tasks to support the implementation and maintenance of the QMS.
- Develop an annual audit plan aligned with ISO15189:2022, and report findings to the Senior Management Team and Laboratory Director.
- Ensure all audit outcomes are thoroughly investigated, actioned, and closed within agreed timelines.
- Promptly investigate incidents (e.g., Datix reports), result errors, and service user complaints with the Laboratory Manager, identifying root causes and implementing corrective actions.
- Ensure preventive actions and process redesigns are carried out effectively to prevent recurrence and enhance service quality.
- Have knowledge of working in a clinical laboratory environment.
- Familiarise with and be knowledgeable in the use of Liquid Chromatography-Mass Spectrometry (LCMS).
- Train staff in QMS and their responsibilities within the QMS, ensuring understanding of ISO15189:2022 and UKAS standards.
- Provide training on audit processes to support internal audit delivery and promote a culture of quality.
- Oversee the department CPD programme and that CPD activities are appropriately recorded.
- Hold regular meetings with staff to review and support CPD ensuring alignment with professional standards.
About us
At Imperial College Healthcare you can achieve extraordinary things with extraordinary people, working with leading clinicians pushing boundaries in patient care.
Become part of a vibrant team living our values - expert, kind, collaborative and aspirational. You'll get an experience like no other and will fast forward your career.
Benefits include career development, flexible working and wellbeing, staff recognition scheme. Make use of optional benefits including Cycle to Work, car lease schemes, season ticket loan or membership options for onsite leisure facilities.
We are committed to equal opportunities and improving the working lives of our staff and will consider applications to work flexibly, part time or job share. Please talk to us at interview. .
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role and the person specification outlines the qualifications, skills, experience and knowledge required.
For both overviews, please view the Job Description attachment with the job advert.
Job description
Job responsibilities
The full job description provides an overview of the key tasks and responsibilities of the role and the person specification outlines the qualifications, skills, experience and knowledge required.
For both overviews, please view the Job Description attachment with the job advert.
Person Specification
Education/ qualifications
Essential
- HCPC Registered
- IBMS accredited honours degree in Biomedical Sciences or IBMS equivalent
- FIBMS or MSc in an appropriate science
- Quality Management qualification or working toward
Experience
Essential
- Experience in the use of Quality Management Systems in a diagnostic laboratory
- Experience in using Q-Pulse at an advanced level
- Experience of using a LIMS system
- Experience of working as a Band 6 Healthcare Scientist (as a minimum)
- Experience in incident reporting, non-conformance and root cause analysis
- Experience in performing audits and managing findings
- Experience with writing and reviewing policies/SOPs
- Good knowledge of QMS, accreditation processes, and a good understanding of the ISO15489:2022 standards
- Proven involvement in UKAS assessments, including preparation, active participation during inspections, and post-assessment follow-up to address findings and maintain accreditation
- Experience of teaching and training staff
- Experience of validation/verification
Desirable
- Experience of leading UKAS assessments
- Experience of working in a therapeutic drug monitoring laboratory
- Experience of managing staff
- Experience of operating specialist clinical laboratory equipment
- Experience of performing LIMS User Acceptance Testing
- Experience of using Q-Pulse CAPA and Assets modules
Skills/knowledge/ abilities
Essential
- Intermediate Microsoft Office user and data analysis skills
- Excellent communication skills, both oral and written
- Time management and prioritisation skills
- Strong organisational and planning skills.
- Be methodical and have high attention to detail
- Be self-motivated and use initiative
- Good interpersonal skills
- Leadership skills with ability to motivate staff
- Work as part of a small team
- Knowledge of QMS, audit, CAPA and RCA processes
- Knowledge of IQA and EQA
- Knowledge and understanding of staff competency assessment
- Knowledge of organising audit schedules
- Ability to train and competency assess staff in QMS processes
Person Specification
Education/ qualifications
Essential
- HCPC Registered
- IBMS accredited honours degree in Biomedical Sciences or IBMS equivalent
- FIBMS or MSc in an appropriate science
- Quality Management qualification or working toward
Experience
Essential
- Experience in the use of Quality Management Systems in a diagnostic laboratory
- Experience in using Q-Pulse at an advanced level
- Experience of using a LIMS system
- Experience of working as a Band 6 Healthcare Scientist (as a minimum)
- Experience in incident reporting, non-conformance and root cause analysis
- Experience in performing audits and managing findings
- Experience with writing and reviewing policies/SOPs
- Good knowledge of QMS, accreditation processes, and a good understanding of the ISO15489:2022 standards
- Proven involvement in UKAS assessments, including preparation, active participation during inspections, and post-assessment follow-up to address findings and maintain accreditation
- Experience of teaching and training staff
- Experience of validation/verification
Desirable
- Experience of leading UKAS assessments
- Experience of working in a therapeutic drug monitoring laboratory
- Experience of managing staff
- Experience of operating specialist clinical laboratory equipment
- Experience of performing LIMS User Acceptance Testing
- Experience of using Q-Pulse CAPA and Assets modules
Skills/knowledge/ abilities
Essential
- Intermediate Microsoft Office user and data analysis skills
- Excellent communication skills, both oral and written
- Time management and prioritisation skills
- Strong organisational and planning skills.
- Be methodical and have high attention to detail
- Be self-motivated and use initiative
- Good interpersonal skills
- Leadership skills with ability to motivate staff
- Work as part of a small team
- Knowledge of QMS, audit, CAPA and RCA processes
- Knowledge of IQA and EQA
- Knowledge and understanding of staff competency assessment
- Knowledge of organising audit schedules
- Ability to train and competency assess staff in QMS processes
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
