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:
Use of the document control system Change control Incident investigation & corrective and preventative actions (CAPA) Internal audits Validations Risk assessment External qualifications and audits as necessary Review of related documentation
Main duties of the job
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 Trust's 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
Employer details
Employer name
The Royal Marsden NHS Foundation Trust
Address
Royal Marsden Hospital Sutton
Sutton
SM2 5PT
Any attachments will be accessible after you click to apply. #J-18808-Ljbffr
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:
Use of the document control system Change control Incident investigation & corrective and preventative actions (CAPA) Internal audits Validations Risk assessment External qualifications and audits as necessary Review of related documentation
Main duties of the job
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 Trust's 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
Employer details
Employer name
The Royal Marsden NHS Foundation Trust
Address
Royal Marsden Hospital Sutton
Sutton
SM2 5PT
Any attachments will be accessible after you click to apply. #J-18808-Ljbffr
