Lead Quality Assurance (QA) Officer

Job overview

An 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. 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 job

• 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.

Detailed job description and main responsibilities

• 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.