About this role
Job summary
An exciting opportunity has arisen to recruit to the role of a Gene Therapy Quality Manager within the Quality Team. The post-holder will support our highly specialised Gene Therapy and Blood and Marrow Transplant (BMT) Programmes, to maintain the effective and efficient delivery of the services' quality agenda.
This is a key leadership and specialist role, providing expert oversight of the Quality Management System (QMS) across adult and children's services, ensuring the highest standards of patient safety, clinical governance, regulatory compliance and continuous quality improvement.
The postholder will play a pivotal role in maintaining and developing quality systems that underpin the delivery of cutting edge, highly regulated cellular and gene therapy services.
Working closely with clinical leaders, senior nurses, laboratory and apheresis teams, external manufacturers and Trust governance teams, you will ensure compliance with the Human Tissue Authority (HTA), JACIE and manufacturer standards, while supporting innovation, service development and exceptional patient care.
Main duties of the job
Lead and oversee the Quality Management System for the Gene Therapy programme within Adult and Paediatric Haematology and BMT. Ensure regulatory and accreditation compliance, including preparation for and maintenance of HTA and JACIE accreditation and adherence to external manufacturer requirements. Lead on clinical governance and patient safety, including the investigation, monitoring and trending of incidents, adverse events, deviations and non conformances, implementing robust corrective and preventative actions. Manage document control for policies, procedures, SOPs, risk assessments and change controls, ensuring systems remain current, accessible and audit ready. Develop, monitor and report on quality performance indicators and KPIs, providing clear verbal and written reports to departmental, divisional and Trust level forums. Lead and support quality improvement initiatives, contributing to service transformation, patient experience and commissioning objectives. Organise, chair and support quality and governance meetings, producing agendas, papers, minutes and action plans. Provide quality and governance training to multidisciplinary staff, promoting a strong quality culture across the service.
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.
Environmental sustainabilityClimate change and poor air quality is a health emergency that harms people's health and wellbeing and widens health inequalities. The Trust is also committed to reducing its impact on the environment by reducing our greenhouse gas emissions to Net Zero by 2045. All our employees have a role to play, and we have an active green network that supports staff to act in ways that ensures that our services are efficient, sustainable and reduce our impact on the environment www.imperial.nhs.uk/about-us/our-strategy/green-plan.
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
Educated to degree level or equivalent
Desirable
Quality Management qualification
Experience Essential
In depth experience of clinical governance systems in healthcare Experience in carrying out root cause analysis for incidents Experience in designing, organising and delivering training in quality and audit Experienced at problem solving
Desirable
Experience in managing an electronic quality management system
Skills/Knowledge/ Abilities Essential
Thorough understanding of JACIE & HTA and their application Proficient in the use of IT, e.g. Microsoft Office Packages (Word, Excel, PowerPoint, Outlook), internet and email. Excellent comprehension skills with ability to negotiate and persuade staff and colleagues at different levels Highly organised with a practical approach to resolving challenges.
Desirable
Knowledge of regulatory inspection and accreditation in the healthcare setting Good understanding of the cellular and gene therapies and application of quality assurance within this field
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 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).
Employer details Employer name Imperial College Healthcare NHS Trust
Address Trust Wide
London
W2 1NY
United Kingdom
Employer's website https://www.imperial.nhs.uk/ (Opens in a new tab)