Job summary
An exciting opportunity has arisen for a highly motivated Quality Assurance professional to join the Newcastle Advanced Therapies Team within the Pharmacy Directorate to deliver a comprehensive support function to the Newcastle upon Tyne Hospitals NHS Foundation Trust covering all activity under a multidisciplinary Human Tissue Authority (HTA) License across the entire Trust.
The postholder will lead the Quality Management process across several clinical disciplines and be responsible for the design and maintenance of Quality Systems including the Quality Manual and associated policies and procedures. Newcastle Advanced Therapies delivers an extensive portfolio of cell and gene therapy services as licenced medicines or to support clinical trials with the postholder providing quality assurance support in the stem cell laboratory setting and across the wider NHS Trust.
The successful candidate will make a significant contribution to maintaining the HTA Licence and in doing so make a direct contribution in supporting the activity that takes place to treat a range of patients in the Newcastle Hospitals.
- Interview Date: 20th July 2023
- 37h 30min. /Week
- You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy.
Main duties of the job
The successful candidate will lead on all Newcastle Hospitals HTA activity, act as the main point of contact and ensure appropriate governance is in place to ensure regulatory compliance. The postholder will work closely with a wide network of designated individuals including scientists, clinicians and pharmacists ensuring appropriate training and audit is in place to attain regulatory accreditations.
The successful candidate will be proactive and self-motivated and be educated to MSc level within a pharmaceutical or biomedical sciences discipline and be able to demonstrate extensive knowledge and experience of Quality Assurance.
The postholder will have significant knowledge of the Human Tissue Authority and be able to demonstrate working knowledge of applying regulatory standards in a clinical and/or laboratory setting. The postholder will be expected to build positive relationships with colleagues across the department, supporting QA requirements in a busy stem cell laboratory and wider Trust.
About us
Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, with over 18,000 staff and an annual income of £1 billion.
Rated 'Outstanding' by theCQC for the second consecutive time in 2019, we have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
We're also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
Our staff oversee around 1.84 million patients 'contacts' each year, delivering high standards of healthcare.
We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.
Job description
Job responsibilities
- To provide a quality assurance support function to Newcastle Hospitals covering all activity under the Trust-wide HTA licence, which comprises the clinical bone marrow transplant service, stem cell laboratories, advanced therapies clinical trials and the storage and retrieval of range of cells and tissues across several clinicaldisciplines.
- Responsible for designing a quality management document control system and supporting the Quality Management process, this will include the production and maintenance of the Quality Manual and Quality Policies associated with the Trust-wide HTA Licence.
- Implement the departmental quality system underpinning clinical service and clinical trials delivery.
- Effective delivery of Quality Assurance support in the provision ofregulatory/accreditation advice (HTA and JACIE), quality performance monitoring and quality management functions within Pharmacy Advanced Therapies and related services.
- Lead on all Trust HTA activity, acting as the main point of contact to ensure appropriate governance is in place. Lead on any updates and change requests associated with the HTA licence on behalf of the Trust.
- To assist in developing quality initiatives to meet regulatory and accreditation requirements and to promote quality principles and practices throughout the department.
- To be responsible for ensuring that all relevant clinical, collection and processing facilities meet the current Joint Accreditation Committee of the International Society for Cellular Therapies and the EBMT standards (JACIE) and to ensure Trust-wide compliance with the Human Tissue Authority (HTA) licence.
- To lead in the preparation, facilitation and process for site audit visits, regulatory inspections, and quality standards accreditation, including process, response and remedial action in the event of any identified non-compliance.
- Verify any corrective action highlighted by reports following external inspections of Advanced Therapies
- Ensure that all quality control procedures are followed, and high analytical standards are maintained.
- The lead in the production of an annual Quality Report and provide information for Management Quality review.
- Responsibility for providing an effective Quality Management service which operates over 24 hours.
- Introduce and supervise a programme of internal vertical and horizontal audit against defined performance quality measures and to ensure that rapid remedial actions are taken in the event of non-compliance.
- Ensure continuation of established techniques and the following of department and Trust protocols and policies by staff members.
- May have additional cross-site responsibilities in designated technical areas in particular the Pharmacy Production Unit and in the areas of advanced therapies clinical trials.
- To support research and development linked to the needs of the Trust, particularly in the provision of advice and guidance in the regulatory considerations associated with ATIMP.
- Deputise for the Designated Individual across the Trust as and when required depending on the needs of the services.
- To establish and lead a group of person designates associated with activity under the HTA licence to share best practice, deliver quality improvements and ensure a robust action plan for each relevant activity.
- To provide advice and guidance across the Trust in matters relating to the HTA and regulatory compliance.
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate.The method of payment is a salary deduction from your first months pay.
Job description
Job responsibilities
- To provide a quality assurance support function to Newcastle Hospitals covering all activity under the Trust-wide HTA licence, which comprises the clinical bone marrow transplant service, stem cell laboratories, advanced therapies clinical trials and the storage and retrieval of range of cells and tissues across several clinicaldisciplines.
- Responsible for designing a quality management document control system and supporting the Quality Management process, this will include the production and maintenance of the Quality Manual and Quality Policies associated with the Trust-wide HTA Licence.
- Implement the departmental quality system underpinning clinical service and clinical trials delivery.
- Effective delivery of Quality Assurance support in the provision ofregulatory/accreditation advice (HTA and JACIE), quality performance monitoring and quality management functions within Pharmacy Advanced Therapies and related services.
- Lead on all Trust HTA activity, acting as the main point of contact to ensure appropriate governance is in place. Lead on any updates and change requests associated with the HTA licence on behalf of the Trust.
- To assist in developing quality initiatives to meet regulatory and accreditation requirements and to promote quality principles and practices throughout the department.
- To be responsible for ensuring that all relevant clinical, collection and processing facilities meet the current Joint Accreditation Committee of the International Society for Cellular Therapies and the EBMT standards (JACIE) and to ensure Trust-wide compliance with the Human Tissue Authority (HTA) licence.
- To lead in the preparation, facilitation and process for site audit visits, regulatory inspections, and quality standards accreditation, including process, response and remedial action in the event of any identified non-compliance.
- Verify any corrective action highlighted by reports following external inspections of Advanced Therapies
- Ensure that all quality control procedures are followed, and high analytical standards are maintained.
- The lead in the production of an annual Quality Report and provide information for Management Quality review.
- Responsibility for providing an effective Quality Management service which operates over 24 hours.
- Introduce and supervise a programme of internal vertical and horizontal audit against defined performance quality measures and to ensure that rapid remedial actions are taken in the event of non-compliance.
- Ensure continuation of established techniques and the following of department and Trust protocols and policies by staff members.
- May have additional cross-site responsibilities in designated technical areas in particular the Pharmacy Production Unit and in the areas of advanced therapies clinical trials.
- To support research and development linked to the needs of the Trust, particularly in the provision of advice and guidance in the regulatory considerations associated with ATIMP.
- Deputise for the Designated Individual across the Trust as and when required depending on the needs of the services.
- To establish and lead a group of person designates associated with activity under the HTA licence to share best practice, deliver quality improvements and ensure a robust action plan for each relevant activity.
- To provide advice and guidance across the Trust in matters relating to the HTA and regulatory compliance.
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate.The method of payment is a salary deduction from your first months pay.
Person Specification
Qualifications & Education
Essential
- Accredited MSc in Clinical Pharmaceutical Sciences or Biomedical Sciences or equivalent qualification.
- Registered with a relevant Professional Body or eligible to apply.
- Higher qualification in Quality Assurance or demonstrable equivalent level of knowledge
Desirable
Knowledge & Experience
Essential
- Knowledge of, and experience in Good Manufacturing Practice and Quality Control relating to the requirements of the Medicines Act 1968.
- Expert knowledge of relevant regulatory standards particularly the Human Tissue Authority
- Experience of Quality Management Systems including document control, incident management and change control
Desirable
- Experience with Q-Pulse document management system
- Working knowledge of JACIE accreditation
- Working knowledge of MHRA regulatory standards
- Experience with Q-Pulse document management system
- Research and Development experience.
Skills & Abilities
Essential
- Ability to use common IT packages effectively (Word, Excel, PowerPoint and Access)
- Advanced keyboard and IT related skills
Person Specification
Qualifications & Education
Essential
- Accredited MSc in Clinical Pharmaceutical Sciences or Biomedical Sciences or equivalent qualification.
- Registered with a relevant Professional Body or eligible to apply.
- Higher qualification in Quality Assurance or demonstrable equivalent level of knowledge
Desirable
Knowledge & Experience
Essential
- Knowledge of, and experience in Good Manufacturing Practice and Quality Control relating to the requirements of the Medicines Act 1968.
- Expert knowledge of relevant regulatory standards particularly the Human Tissue Authority
- Experience of Quality Management Systems including document control, incident management and change control
Desirable
- Experience with Q-Pulse document management system
- Working knowledge of JACIE accreditation
- Working knowledge of MHRA regulatory standards
- Experience with Q-Pulse document management system
- Research and Development experience.
Skills & Abilities
Essential
- Ability to use common IT packages effectively (Word, Excel, PowerPoint and Access)
- Advanced keyboard and IT related skills
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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