Deputy Head of Quality

at  Northumbria Healthcare NHCT Northumbria Healthcare NHS Foundation Trust

An exceptional opportunity has arisen to provide Quality leadership within the purpose built Medicines Manufacturing Centre (MMC). Based in Seaton Delaval, Northumberland, the MMC will produce sterile injectable medicinal products in line with MHRA Good Manufacturing Practice on behalf of the North East and North Cumbria Provider Collaborative.
The post holder will act as Deputy Head of Quality and will be responsible for assuring the quality of medicines, for all of the pharmaceutical quality systems across the MMC and the management of the Quality team.
To provide leadership on Quality related aspects within the MMC .
To meet clinical needs within the Integrated Care Services (ICS) for ready to use sterile injectable medicinal products.
To support the establishment of the MMC, as a leading Manufacturing Centre within the national NHS framework for aseptic transformation.
The MMC is in the late stages of design, with the facility build phase planned through to September 2025. This presents an exciting opportunity to be involved in the design and build of a new facility, the development of new production process and contribution to establishing a functional PQS for the facility.
A successful candidate will be integral in establishing the quality team for the delivery of anti-cancer and ready-to-administer sterile medicines for use in all 8 acute NHS Trusts in the NENC region.
Staff will be employed by Northumbria Healthcare Foundation NHS Trust until the formation of the Medicines Manufacturing Centre Legal Liability Partnership (LLP) is formed as a legal entity, after which TUPE regulations will apply.
To act as deputy for the Head of Quality where appropriate.
To provide leadership on Quality Assurance (QA) related aspects within the MMC.
To manage and train the team releasing products manufactured under the MHRA Specials Licence.
Implement quality policies which complies with Good Manufacturing Practice.
To lead in the review and approval of user requirement specifications for manufacturing equipment.
To chair / sub-chair the Quality Management Meeting leading and ensuring appropriate pharmaceutical quality systems are in place in all departments of the MMC.
To lead on investigations involving the quality of pharmaceutical products across the MMC.
To perform QA Specialist functions, including external supplier audits, QA input into procurement, education and training, and advising colleagues in other Trusts in North East and North Cumbria.

Please refer the Job description for details