Job summary
Cambridge Cellular Therapy Laboratory (CCTL) is seeking an experienced Head of Quality (Band 8a) to lead QA and QC across our advanced therapy manufacturing facilities. You will oversee the Quality Management System, ensure compliance with MHRA, HTA and JACIE standards, and provide expert support for clinical trials and GMP operations. Working closely with the Director and Senior Operations Team, you will lead quality strategy, regulatory oversight, and staff training, contributing to the safe and effective delivery of cell therapy products for NHS patients and research partners. This is a key role for a motivated quality professional looking to make a significant impact in a growing, innovative service.
Main duties of the job
Lead and develop the CCTL Pharmaceutical QMS and provide independent expert advice on all Quality matters. Ensure compliance with MHRA (GMP), HTA and JACIE requirements. Act as HTA Persons Designate and support the Quality Controller on Specials and IMP licences. Oversee QA and QC services, support clinical trial quality requirements, and contribute to facility validation and qualification. Line manage the Quality Team, act as Training Manager, and deliver QMS and regulatory training. Provide QA/QC support to internal teams and external partners including NNUH, Ipswich and University of Cambridge collaborators.
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 13,000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Due to Home Office immigration rules, a full time permanent vacancy cannot be filled by individuals on a Student visa. Therefore, please be advised that if you are a Student visa holder, we will not be able to offer you a full time permanent contract unless you have:- applied for a Graduate visa- or you will have successfully completed your course and have applied for a Graduate visa before the anticipated start date of your employment- or the Trust has agreed that they will Sponsor you as a Skilled Worker and you will complete your studies within 3 months of the anticipated start date of employment
This vacancy will close at midnight on 22nd February 2026.
Interviews are due to be held on 5th March 2026.
Benefits to you
At Cambridge University Hospitals, we want to do all we can to support good working days. We offer development opportunities and a wide range of benefits, including on-site leisure facilities, shopping concourse and day nurseries. Our good work programme currently includes providing reduced cost Stagecoach bus travel to and from Cambridge University Hospital site. Park and Ride bus journeys between Babraham Road and Trumpington sites are free, as is the route to and from Cambridge train station and our hospitals. We also subsidise the cost of parking on site for eligible staff.
On CUH campus, hot food is available 24/7 and at a reduced cost for colleagues. Recently we launched the first of our staff pod break spaces. Located in the Deakin Centre, we have a purpose-created colleague-only caf, with free tea and coffee, a break space and private outside area for colleagues to rest, refuel and recharge. Just one of the ways we are working hard to support good working days at CUH.
CUH is committed to assisting employees in achieving a good work-life balance irrespective of role or personal circumstances. Flexible arrangements may include, but are not limited to, part-time working, job-share, term-time working and flexible start and finish times.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Due to Home Office immigration rules, a full time permanent vacancy cannot be filled by individuals on a Student visa. Therefore, please be advised that if you are a Student visa holder, we will not be able to offer you a full time permanent contract unless you have:- applied for a Graduate visa- or you will have successfully completed your course and have applied for a Graduate visa before the anticipated start date of your employment- or the Trust has agreed that they will Sponsor you as a Skilled Worker and you will complete your studies within 3 months of the anticipated start date of employment
This vacancy will close at midnight on 22nd February 2026.
Interviews are due to be held on 5th March 2026.
Benefits to you
At Cambridge University Hospitals, we want to do all we can to support good working days. We offer development opportunities and a wide range of benefits, including on-site leisure facilities, shopping concourse and day nurseries. Our good work programme currently includes providing reduced cost Stagecoach bus travel to and from Cambridge University Hospital site. Park and Ride bus journeys between Babraham Road and Trumpington sites are free, as is the route to and from Cambridge train station and our hospitals. We also subsidise the cost of parking on site for eligible staff.
On CUH campus, hot food is available 24/7 and at a reduced cost for colleagues. Recently we launched the first of our staff pod break spaces. Located in the Deakin Centre, we have a purpose-created colleague-only caf, with free tea and coffee, a break space and private outside area for colleagues to rest, refuel and recharge. Just one of the ways we are working hard to support good working days at CUH.
CUH is committed to assisting employees in achieving a good work-life balance irrespective of role or personal circumstances. Flexible arrangements may include, but are not limited to, part-time working, job-share, term-time working and flexible start and finish times.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person Specification
Qualifications
Essential
- BSc or equivalent
- Masters degree or equivalent in Pharmacy, Quality Management or a science based discipline
- Evidence of professional continuous development and portfolio of learning
Desirable
- Leadership qualification
- Quality qualification
Experience
Essential
- Significant experience in Quality Management relating to BMT programme, HTA licenced cells/tissue for Human Use and/or aseptic manufacture of MHRA licenced medicines
- Statistical analysis
- Extensive experience of managing an electronic Quality Management System, including modification; preferably Quality Manager (previously QPulse)
- Experience using a LIMS
- Significant managerial experience in a JACIE accredited and/or HTA/MHRA licensed facility
- Experience in audit
- Experience in personnel training
- Experience in multi-disciplinary team working
- Experience of working in a Clean Room environment
- Evidence of leading a service change in a medical laboratory
- Working to GMP
Desirable
- Experience with immune effector cells in human use
- Experience of involvement with ATIMPs
- Management and use of Ultra Low Temperature storage including liaison for re-evacuation of Super Insulated Vacuum Lines.
- Experience of out of hours working
- Experience of setting up and modifying an eQMS
- Experience of initial and on-going validation of clean room
Knowledge
Essential
- Practical knowledge of GCP, GMP, JACIE, HTA, QA and all current relevant regulations.
- Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products
- Demonstrated knowledge required to ensure quality through the set-up, manufacturing/ processing and release of cellular therapy products under a manufacturing or HTA licence, to comply fully with the requirements of GMP, GCP and/or HTA as appropriate.
- Ability to evaluate and improve service quality
- Ability to provide a strategic vision for Quality Assurance
- Expert technical knowledge of pharmaceutical QA and GMP and a proven ability to apply this to maintain and develop quality systems
- Fully Microsoft Office Literate
Desirable
- Haemopoietic transplants
- Flow cytometry
- PCR
- Immunology
- Health and safety procedures in a laboratory handling GMO
- Database management
- Pharmaceutical microbiology
- Idegen Quality Manager
Skills
Essential
- Advanced communication skills, verbal and written. Including the communication of complex, contentious and sensitive information effectively, using clear written and spoken English.
- Able to communicate and interact with multidisciplinary, cross-speciality healthcare teams including regional Consultants and other Quality Experts across the UK and globally.
- Ability to promote and evaluate best practice within the QA and manufacturing service
- Able to work both in a team and as an individual
- Ability to work in an organised manner, to high standards and with a very high level of accuracy and precision
- Good time management, self-motivated, ability to multi-task, ability to concentrate for long periods
- The ability to problem solve and troubleshoot, including ability to solve difficult and ambiguous problems by advanced reasoning and sound technical judgment
- Proven ability to cope under pressure
- Able to respond to change, apply themselves to development in practice and influence the response of others
- Ability to build and manage an efficient, happy team
Desirable
- Presentation skills
- Manual dexterity
- Ability to inspect final products
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of kind, safe and excellent. This behaviour is outlined on the final page of this person specification
- Highly motivated, reliable and supportive
- Committed to continuous service development
Person Specification
Qualifications
Essential
- BSc or equivalent
- Masters degree or equivalent in Pharmacy, Quality Management or a science based discipline
- Evidence of professional continuous development and portfolio of learning
Desirable
- Leadership qualification
- Quality qualification
Experience
Essential
- Significant experience in Quality Management relating to BMT programme, HTA licenced cells/tissue for Human Use and/or aseptic manufacture of MHRA licenced medicines
- Statistical analysis
- Extensive experience of managing an electronic Quality Management System, including modification; preferably Quality Manager (previously QPulse)
- Experience using a LIMS
- Significant managerial experience in a JACIE accredited and/or HTA/MHRA licensed facility
- Experience in audit
- Experience in personnel training
- Experience in multi-disciplinary team working
- Experience of working in a Clean Room environment
- Evidence of leading a service change in a medical laboratory
- Working to GMP
Desirable
- Experience with immune effector cells in human use
- Experience of involvement with ATIMPs
- Management and use of Ultra Low Temperature storage including liaison for re-evacuation of Super Insulated Vacuum Lines.
- Experience of out of hours working
- Experience of setting up and modifying an eQMS
- Experience of initial and on-going validation of clean room
Knowledge
Essential
- Practical knowledge of GCP, GMP, JACIE, HTA, QA and all current relevant regulations.
- Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products
- Demonstrated knowledge required to ensure quality through the set-up, manufacturing/ processing and release of cellular therapy products under a manufacturing or HTA licence, to comply fully with the requirements of GMP, GCP and/or HTA as appropriate.
- Ability to evaluate and improve service quality
- Ability to provide a strategic vision for Quality Assurance
- Expert technical knowledge of pharmaceutical QA and GMP and a proven ability to apply this to maintain and develop quality systems
- Fully Microsoft Office Literate
Desirable
- Haemopoietic transplants
- Flow cytometry
- PCR
- Immunology
- Health and safety procedures in a laboratory handling GMO
- Database management
- Pharmaceutical microbiology
- Idegen Quality Manager
Skills
Essential
- Advanced communication skills, verbal and written. Including the communication of complex, contentious and sensitive information effectively, using clear written and spoken English.
- Able to communicate and interact with multidisciplinary, cross-speciality healthcare teams including regional Consultants and other Quality Experts across the UK and globally.
- Ability to promote and evaluate best practice within the QA and manufacturing service
- Able to work both in a team and as an individual
- Ability to work in an organised manner, to high standards and with a very high level of accuracy and precision
- Good time management, self-motivated, ability to multi-task, ability to concentrate for long periods
- The ability to problem solve and troubleshoot, including ability to solve difficult and ambiguous problems by advanced reasoning and sound technical judgment
- Proven ability to cope under pressure
- Able to respond to change, apply themselves to development in practice and influence the response of others
- Ability to build and manage an efficient, happy team
Desirable
- Presentation skills
- Manual dexterity
- Ability to inspect final products
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of kind, safe and excellent. This behaviour is outlined on the final page of this person specification
- Highly motivated, reliable and supportive
- Committed to continuous service development
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).