Lead Quality Assurance

All employees of the Medicine Manufacturing Centre (MMC) are currently employed by Northumbria Healthcare NHS Foundation Trust, under Agenda for Change Terms and Conditions. Should the service be transferred into alternative ownership, those employees with start dates prior to the transfer date, will be protected under Transfer of Undertakings (Protection of Employment) Regulations 2006 (TUPE). Therefore, employees will transfer to the new employer on the same terms and conditions, which are protected and the employees’ continuity of employment is preserved
To contribute to the delivery of a GMP compliant manufacturing facility that optimises the regional benefit from the £30 million funding provided by NHSE.
Support QA activities for products and processes under the MMC’s MS Licence, ensuring the compliance with MHRA and NHS standards.
Provides technical QA resource, advice, and support to ensure GMP compliance at the MMC.
Responsible for managing and training Quality Assurance staff.
Manages the team that assures the quality of and release unlicensed medicines to the value of approximately £20 million per annum.
The Medicines Manufacturing Centre (MMC) is a brand-new, purpose-built NHS pharmaceutical production facility located at the Northumbria Innovation and Manufacturing Hub in Seaton Delaval, Northumberland. This cutting-edge centre is part of the North East and North Cumbria Provider Collaborative and has been established to meet the growing need for high-quality, regionally manufactured Ready-to-Administer (RtA) medicines and advanced aseptic products.
Funded with £30 million of investment from NHS England, the MMC will support a secure, sustainable supply chain for critical medicines, particularly for oncology and other high-risk therapies, while creating skilled jobs and driving innovation across the region. The facility is designed to operate under a Manufacturer’s Specials Licence (MS) and aims to secure a Wholesale Dealer’s Authorisation (WDA(H)), ensuring compliance with MHRA, GMP, and GDP regulations from day one.
At the MMC, quality, patient safety, and staff wellbeing are at the heart of everything we do. Our leadership team is committed to building a culture of openness, learning, and continuous improvement—offering staff a rare opportunity to help shape the systems, teams, and values of a truly modern NHS manufacturing unit.
Working at the MMC means being part of a forward-thinking and supportive team focused on enabling frontline clinical staff to spend more time with patients by delivering safe, ready-to-use medicines.
To support and maintain the Pharmaceutical Quality System (PQS) within the Medicines Manufacturing Centre (MMC), ensuring compliance with Good Manufacturing Practice (GMP), NHS guidance, and MHRA regulations.
To complete relevant aspects of the PQS reporting systems e.g. Documentation Control, revision and approval, Change Control, Deviations, Quality Risk Assessments, Root Cause Analysis, Micro non-conformances, Complaints, Supplier Approval, Key Performance Indicator Trending, Quality Technical Agreements and Training Processes.
To co-ordinate and perform the review, approval, and monitoring of QA processes, documentation, and release of products, as well as ensuring continuous improvement and regulatory compliance.
To participate on investigations involving the quality of pharmaceutical products across the MMC
To manage the Quality Assurance staff during day-to-day operations and longer-term planning
To plan and implement a strategy to ensure a robust and fit for purpose Quality Assurance workforce throughout the product lifecycle
To develop and monitor quality KPIs which demonstrate the state of control of the facility, and report these to the senior management team
To role model compassionate and inclusive leadership to shape the creation of a collective leadership culture within the Trust. This means demonstrating a consistent leadership style which (a) engages, enables and empowers others (b) uses coaching to promote ownership of learning and quality improvement and (c)
facilitates team working and collaboration within teams / departments and across organisational boundaries.