Northumbria Healthcare NHS Foundation Trust
Quality Assurance Validation Manager
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QA Validation Manager
An exciting opportunity has arisen for a QA Validation Manager to play a key role in ensuring compliance with EU GMP at the Medicines Manufacturing Centre (MMC). Based in Seaton Delaval, Northumberland, the MMC is a state-of-the-art NHS facility dedicated to the sterile manufacture of injectable medicinal products.
Operating under MHRA Good Manufacturing Practice (GMP) standards, the MMC ensures a secure supply chain for Systemic Anti-Cancer Therapy (SACT) products, while delivering Ready-to-Administer (RtA) medicines to enable nurses to spend more time on patient care.
Responsibilities
As a QA Validation Manager, you will be the subject matter expert in QA validation, leading all validation activities within the MMC and ensuring compliance with EU GMP and regulatory requirements. You will manage core Pharmaceutical Quality Systems (PQS) in relation to validation, and provide leadership in maintaining operations excellence, product safety, and regulatory compliance.
- Lead validation activities and ensure compliance with EU GMP across all processes within the MMC.
- Manage core Pharmaceutical Quality Systems (PQS) related to equipment management, including validation, maintenance, and repairs.
- Oversee outsourced activities, including contractor management, supplier approval, and quality technical agreements.
- Lead New Product Introduction (NPI) processes and Quality Risk Management (QRM) for critical process parameters and product quality reviews.
- Provide QA oversight on various process validations such as cleaning, transport, temperature mapping, and QC method validation.
- Lead the site-wide approach to computerized system validation, data integrity, and GMP requirements.
- Manage contamination control strategy (CCS) and environmental monitoring in collaboration with site microbiology teams
- Lead and develop the QA validation team, ensuring training, performance, and continuous improvement initiatives are met.
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About the Medicines Manufacturing Centre (MMC)
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.
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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.
Contact Information
For further details / informal visits contact:
- Name: Laura Davies
- Job title: Head of Quality
- Email address: laura.davies1@nenc-mmc.nhs.uk
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.
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