Quality Assurance Officer

An exciting opportunity has arisen for a highly organised and proactive Quality Assurance Officer to join the Medicines Manufacturing Centre (MMC)—a cutting-edge NHS pharmaceutical production facility based in Seaton Delaval, Northumberland.
The MMC is in its final design stages, with facility construction planned through to September 2025. Initially, staff will be employed by Northumbria Healthcare Foundation NHS Trust, with employment transferring to the Medicines Manufacturing Centre Legal Liability Partnership (LLP) upon its formation under TUPE regulations.
This is a fantastic opportunity to be part of a pioneering NHS manufacturing facility, supporting a leadership team committed to quality, innovation, and patient care.
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.
We manage three major locality hospitals at North Tyneside, Wansbeck and Hexham, plus a number of smaller community hospitals and clinics from Tynemouth to Berwick on Tweed, in addition to our state-of-the-art Northumbria Specialist Emergency Care Hospital, the first of its kind in England. We also care for people in their homes and provide services from facilities in local communities such as health centres. We give people greater choice and control over their care to help them to live independently at home and avoid hospital admission where appropriate. High quality patient care is at the heart of everything we do and we strive to ensure every single patient and service user has an exceptional experience with us. We have one of the most extensive patient experience programmes of any trust in England.
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.