Job summary An exciting opportunity has arisen for a Quality Officer for the Cellular Therapy Programme at The Royal Marsden NHS Foundation Trust. Commissioned products and clinical trials involving novel cell therapies are transforming care for patients and the trust is committed to supporting pioneering research in this area. Use of these evolving therapies must meet demanding standards set by regulatory bodies to ensure patient safety and full traceability of tissues and cells. The post holder will be responsible for compliance of the delivery of commissioned Cell Therapy products and advanced therapeutic investigational medicinal products (ATIMPS) within the regulatory requirements of the Human Tissue Authority and JACIE as well as clinical trial sponsors. This will include the following elements of the quality management system: o Use of the document control systemo Change controlo Incident investigation & corrective and preventative actions (CAPA)o Internal auditso Validationso Risk assessmento External qualification and audits as necessaryo Review of related documentation Main duties of the job Commissioned products and clinical trials involving novel cell therapies are transforming care for patients and the trust is committed to supporting pioneering research in this area. Use of these evolving therapies must meet demanding standards set by regulatory bodies to ensure patient safety and full traceability of tissues and cells. The post holder will be responsible for compliance of the delivery of commissioned Cell Therapy products and advanced therapeutic investigational medicinal products (ATIMPS) within the regulatory requirements of the Human Tissue Authority and JACIE as well as clinical trial sponsors. About us The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital. At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do. At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements. Date posted 28 January 2025 Pay scheme Agenda for change Band Band 7 Salary £51,883 to £58,544 a year Per Annum Contract Permanent Working pattern Full-time Reference number 282-C124 Job locations Royal Marsden Hospital Sutton Sutton SM2 5PT Job description Job responsibilities For further information on this role, please see the attached detailed Job Description and Person Specification: To ensure along with the DI that commissioned cellular therapy products and ATIMPs meet regulatory requirements To provide support and expert advice to clinical research teams in meeting Human Tissue Authority (HTA) and JACIE requirements To work under the direction of and to communicate regularly with the Trusts HTA Designated Individual (DI) for the Human Application licence. To keep up-to-date on legislative requirements and make recommendations for subsequent operational changes To ensure full traceability of tissues and cells from collection to infusion or disposal along with the wider quality team. Job description Job responsibilities For further information on this role, please see the attached detailed Job Description and Person Specification: To ensure along with the DI that commissioned cellular therapy products and ATIMPs meet regulatory requirements To provide support and expert advice to clinical research teams in meeting Human Tissue Authority (HTA) and JACIE requirements To work under the direction of and to communicate regularly with the Trusts HTA Designated Individual (DI) for the Human Application licence. To keep up-to-date on legislative requirements and make recommendations for subsequent operational changes To ensure full traceability of tissues and cells from collection to infusion or disposal along with the wider quality team. Person Specification Qualifications Essential Undergraduate Degree in a life sciences or related discipline or equivalent experience in clinical research or stem cell transplantation Experience Essential Experience of working to regulatory standards Experience of working in the NHS or relevant clinical / research environment Proven ability to develop effective working relationships with staff at all levels Experience of working to the standards of the Human Tissue Authority (HTA) or JACIE Experience of clinical trials Knowledge of risk management, integrated governance and information governance Desirable Experience of laboratory working Experience of working in clinical research administration Ability to read and understand clinical research protocols Experience of regulatory inspections Experience of design and delivery of training Experience of validation of IT systems Skills Essential Excellent administrative and organisational skills Ability to work using own initiative Ability to clearly summarise and explain complex issues to both technical and non-technical audiences, both in written form and through presentations Understanding of HTA human application requirements Ability to design, perform, analyse collected data and present audits Understanding of quality management systems Able to develop and deliver appropriate education and training Able to work independently with management oversight Physical Essential Able to work on both sites and to be flexible to meet the needs of the role Good Health/Attendance Records Person Specification Qualifications Essential Undergraduate Degree in a life sciences or related discipline or equivalent experience in clinical research or stem cell transplantation Experience Essential Experience of working to regulatory standards Experience of working in the NHS or relevant clinical / research environment Proven ability to develop effective working relationships with staff at all levels Experience of working to the standards of the Human Tissue Authority (HTA) or JACIE Experience of clinical trials Knowledge of risk management, integrated governance and information governance Desirable Experience of laboratory working Experience of working in clinical research administration Ability to read and understand clinical research protocols Experience of regulatory inspections Experience of design and delivery of training Experience of validation of IT systems Skills Essential Excellent administrative and organisational skills Ability to work using own initiative Ability to clearly summarise and explain complex issues to both technical and non-technical audiences, both in written form and through presentations Understanding of HTA human application requirements Ability to design, perform, analyse collected data and present audits Understanding of quality management systems Able to develop and deliver appropriate education and training Able to work independently with management oversight Physical Essential Able to work on both sites and to be flexible to meet the needs of the role Good Health/Attendance Records 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). 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 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 The Royal Marsden NHS Foundation Trust Address Royal Marsden Hospital Sutton Sutton SM2 5PT Employer's website https://www.royalmarsden.nhs.uk/working-royal-marsden (Opens in a new tab)