Job summary

A talented and motivated Quality Manager is sought to work closely with the WCTU Laboratory Director (HTA Designated Individual) and WCTU Laboratory Manager to ensure that the stem cell laboratory meets HTA regulatory requirements and JACIE standards.

The post holder will also work closely with the wider cellular therapies team to obtain a HTA license for tissue procurement and support the establishment of treatment pathways for TIL therapy.

UCLH has a world class cancer service and is one of the largest stem cell transplant and CAR-T centres in Europe. We are very excited to be further expanding our service into Oncology, particularly with tumour-infiltrating lymphocytes (TILs) and non-malignant indications.

Main duties of the job

The post holder will work alongside a team of quality managers to maintain the quality management system on behalf of the Stem Cell Transplant Programme. The post holder will be required to lead/co-lead on regulatory inspections and JACIE inspections, and where necessary partake in trial or licensed product onboarding as required.

In addition, the post-holder will work towards obtaining a HTA license for tissue procurement for starting material of Oncology Advanced Therapy Medicinal products (ATMPs), with an additional opportunity to become the designated individual for the license once obtained.

The post holder must have excellent IT skills, be well organized and methodical with good communication skills. On the job training for our quality management software (Q-Pulse) will be provided.

About us

University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.

We provide first-class acute and specialist services across eight sites:

University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)

National Hospital for Neurology and Neurosurgery

Royal National ENT and Eastman Dental Hospitals

University College Hospital Grafton Way Building

Royal London Hospital for Integrated Medicine

University College Hospital Macmillan Cancer Centre

The Hospital for Tropical Diseases

University College Hospital at Westmoreland Street

We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological,gastrointestinaland oral disease. It has world class support services including critical care, imaging, nuclearmedicineand pathology.

We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.

Job description

Job responsibilities

For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.

Come and be a part of the best NHS trust in England to work for, according to our staff*

UCLH top trust to work at in England for the second year running! : University College London Hospitals NHS Foundation Trust

*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England for the second year in a row.

UCLH top trust to work at in England for the second year running! : University College London Hospitals NHS Foundation Trust.

Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.

Person Specification

Knowledge and Qualifications

Essential

Educated to a degree level or equivalent Relevant post-graduate training in quality management or equivalent experience in quality management Knowledge of the NHS or other healthcare system(s) Knowledge of clinical aspects of cellular therapies and stem cell transplantation Familiar and competent with research methodology and clinical audit Experience and knowledge of the components of clinical governance processes, incdent response and management as well as risk management and change control.

Desirable

Q-Pulse Administration

Experience

Essential

A good working knowledge and understanding of the HTA Tissues and cells directives A good working knowledge of JACIE requirements. Experience of leading on internal audits and external audits/accreditation Experience of supporting education, development and training. Experience in compiling and implementing policies and procedures that promote quality and service improvement.

Desirable

Previous involvement in the management of clinical trials according to GMP and GCP.

Skills and Abilities

Essential

Able to prioritise and manage own workload Able to work collaboratively and effectively with others at all levels Good problem solving and time management skills Able to collate and analyse complex information and produce reports and presentations for a wide variety of audiences Proficient in the use of IT, Word, Excel, PowerPoint, Access, internet and email.

Communication

Essential

Good communication Skills (verbal, non-verbal and written). Able to negotiate and persuade staff and colleagues at different levels

Personal and People Development

Essential

Evidence of continuous personal and professional development Able to organise, multi-disciplinary workshops and training events

Responsibilities towards promoting Equality Diversity and Inclusion

Essential

Demonstratable understanding of the Equality, Diversity, and Inclusion and/or Knowledge of the NHS obligations under the Equality Act 2010 and the Public Sector Equality Duties