Lead Quality Assurance (QA) Officer

Go back Northumbria Healthcare NHS Foundation Trust Lead Quality Assurance (QA) OfficerThe closing date is 03 September 2025An exciting opportunity has arisen for a proactive and passionate 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. 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. Please note we reserve the right to close this vacancy prior to the closing date once the required number of suitable applications have been received. 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 Main duties of the jobTo 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. About usThe 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. Job responsibilitiesTo support and maintain the Pharmaceutical Quality System (PQS) within theMedicines 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 RiskAssessments, 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. Person SpecificationQualifications / Professional RegistrationDegree in Pharmacy, Chemistry, Biology, or a related scientific field or equivalent experience. Or Basic qualification in pharmaceutical sciences (BTEC) or an equivalent scientific qualification to same level with a Postgraduate Diploma in Pharmaceutical Technology or similar. Eligible to be registered with the General Pharmaceutical Council (GPhC), Health and Care Professions Council (HCPC), Royal Society for Chemistry (RSC) or Royal Society for Biology (RSB) or Royal Pharmaceutical Society (RPS). Master Qualification in a scientific discipline (preferably in Pharmaceutical Manufacture) or be willing to work towards a Diploma / Master's degree while in post. Professional Registration Experience and knowledgeKnowledge of GMP and MHRA guidelines and experience of working in a regulated environment. Extensive experience in the management and maintenance of pharmaceutical quality systems. Evidence of continuing education/professional CPD Evidence of managing product release. Evidence of successfully managing a team Experience in manufacture of sterile medicines Experience of training colleagues in GMP Knowledge of or experience in coaching and mentoring practices and tools Knowledge of or experience in Quality improvement tools, techniques and methods. Disclosure and Barring Service CheckThis 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. Northumbria Healthcare NHS Foundation Trust#J-18808-Ljbffr

Created: 2025-08-23