Quality Assurance Validation Manager

Job overview

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.

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.

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.

Main duties of the job

• You will be responsible for managing validation systems and quality assurance processes, ensuring that MMC operates within MHRA and EU GMP guidelines. You will also play a key leadership role in developing the QA Validation team, establishing a culture of quality, continuous learning, and 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.

Detailed job description and main responsibilities

• To act as the Validation Subject Matter Expert (SME) within the MMC, providing leadership in all validation activities to ensure they are all carried out in compliance with EU GMP.
• To introduce and manage core Pharmaceutical Quality Systems (PQS) in relation to equipment management i.e. Validation Master Plan (VMP), New equipment introduction processes, equipment validation, revalidation, repairs, planned preventative maintenance (PPM), Permit to work (PTW).
• To lead Outsourced Activity management of contractors e.g. supplier approval of contractors, Quality Technical Agreements, Monitoring of outsourced activity reporting system and supplier review.
• To introduce and manage core Pharmaceutical Quality Systems (PQS) in relation to New Product Introduction and act as the Quality Risk Management (QRM) lead for process design e.g. Critical Process Parameters (CPP) / Critical Quality Attributes (CQA) and Product Quality Reviews (PQR).
• To provide specialist QA oversight of Process Validations such as Aseptic Process Simulation (APS), operator validation, gowning validation, transfer disinfection, cleaning validation / residue testing, transport validation, temperature mapping, container / closure validation and QC method validation in collaboration with the Quality Control and Production teams.
• To lead the site wide approach to computerised system validation and data integrity GMP requirements.
• To oversee the Contamination Control Strategy (CCS) and environmental monitoring programme in collaboration with the Site Microbiologist and the wider team. To build and manage the QA capacity planning.
• To manage and oversee unit crisis management procedures and planned, and unplanned site shutdown.
• To manage the QA validation team, consisting of validation specialists and computerised system validators.
• To develop and execute training plans for QA validation team.
• Deliver training on relevant QA systems site wide.
• To role model compassionate and inclusive leadership in order 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.