Job Advert
Location – Jack Copland Centre, Edinburgh
As a vital part of NHS Scotland, NHS National Services Scotland’s purpose is to support Scotland’s Health. We do this by providing a range of specialised support services that enable NHS Boards to focus their efforts on health improvement and delivering world class patient care. The core purpose of the Scottish National Blood Transfusion Service is to meet the transfusion needs of patients in Scotland. We are building on our strong foundation as a trusted partner, anticipating the needs of the people of Scotland by expanding our range of life-giving blood products, tissues and innovative advanced therapies, in order to transform lives.
In support of this SNBTS Quality and Regulatory Compliance develops and delivers a Quality Management System throughout SNBTS, which ensures compliant, high quality, efficient processes from donor to patient. Regulatory Compliance sits as a key function within this department, with a view to delivering regulatory compliance for SNBTS. This small team is expanding and as a result a new post has become available.
SNBTS undertakes activity regulated by several regulators and accreditation bodies which include (but are not limited to) the MHRA; Blood, Manufacturing (MIA(IMP), MIA, Specials) and Wholesale dealing), Human Tissue Authority, HFEA, UKAS and JACIE. Licensing and accreditation is essential to enable SNBTS to continue to supply blood, tissues, cells and Advanced Therapy Medicinal Products.
As a result, SNBTS operates within an increasingly complex and diverse regulatory framework. It is the role of the Regulatory Compliance team to navigate relevant regulations, guidance and standards to facilitate awareness, compliance and to deliver regulatory submissions in support of SNBTS projects and strategies.
The Regulatory Compliance Officer is a key member of a small team who is required to interpret regulations and guidance in consultation with colleagues to determine the application of these within SNBTS.
The post holder will be required to be forward thinking and imaginative with the drive and self-motivation to deliver regulatory submissions to achieve approvals to support the SNBTS strategy including, Preparation Process Dossiers to the HTA, Clinical Trial Applications including writing of IMPDs to the MHRA, as well as providing regulatory support and guidance across all Directorates (Donor Services, Blood Processing and Testing, Patient Services, National Microbiology Reference Unit, Tissue, Cells and Advanced Therapies).
This is an exciting opportunity to be part of this expanding team.
Applicants for this Post should hold a Degree in a scientific, biomedical or other relevant subject and have experience of working to the requirements of a Quality Management System in a regulated GxP environment such as Transfusion Service delivery or commercial pharmaceutical or device manufacture. The applicant should have awareness of the regulatory framework mentioned above. Direct experience in the preparation of regulatory submissions will be an advantage.
Currently there is no routine requirement for “out of hours” or shift working for this post. The post is based the SNBTS Jack Copland Centre site, there will be a requirement to visit other SNBTS Centres from time to time as part of the role of the Post.
Our benefits package includes pension scheme, comprehensive range of work life balance policies, occupational health services, learning resource centres and discounted leisure, financial and shopping benefits.
The successful candidate will be required to undergo a PVG Scheme Disclosure/Disclosure Scotland check. Any candidate who has worked overseas for more than 3 months will also be required to provide a criminal record check from the appropriate overseas agency
For an informal discussion on the post, please contact Emily Hargreaves Regulatory Compliance Manager on Tel: 0131 3145591 or 07931 538645
Further information on NSS is available from: https://www.nss.nhs.scot/
Closing date for completed applications is the 24th March 2022
Please note that the majority of correspondence is sent by e-mail only, so please check your e-mail regularly (including junk folders).
NHS National Services Scotland is an equal opportunities employer and as committed participant in the disability confident scheme, guarantees to interview all disabled applicants who meet the minimum criteria for our vacancies