Job summary An exciting opportunity has arisen for a QA Validation Specialist 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. About us 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. Date posted 04 March 2025 Pay scheme Agenda for change Band Band 8a Salary £53,755 to £60,504 a year per annum Contract Permanent Working pattern Full-time, Flexible working, Compressed hours Reference number 319-7032015JN Job locations Manufacturing and Innovation Hub Avenue Road Seaton Delaval NE25 0QJ Job description Job 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 leadershipstyle 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. Job description Job 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 leadershipstyle 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 Specification Qualifications / Professional Registration Essential Degree in relevant scientific discipline or equivalent experience. Master Qualification in a scientific discipline (preferably in Pharmaceutical Manufacture) or equivalent demonstrable experience. Eligible for Professional Registration e.g.General Pharmaceutical Council (GPhC), Health and Care Professions Council HCPC or Royal Society for Chemistry (RSC),Royal Society for Biology (RSB), Royal Pharmaceutical Society (RPS). Post graduate qualification in Pharmaceutical Validation / Quality Assurance or equivalent experience. Desirable Management qualification Professional Registration Experience and knowledge Essential Post qualification experience in Pharmaceutical Manufacturing, Pharmaceutical Quality Control or Quality Assurance. Experience of Quality Risk Management (QRM) and it's application in process design Extensive experience in the management and maintenance of pharmaceutical quality systems. Such as: Deviations, Change Control, Root Cause Analysis, CAPA, Quality Risk Management, Complaints, Recall, Supplier approval and management of outsourced activity. Evidence of continuing education/professional CPD. Detailed knowledge of MHRA Guidance on GxP Data Integrity Requirements, and evidence of application in a GMP environment Desirable Experience of computerised systems validation as per EU GMP Annex 11 Demonstrated experience of working in sterile manufacture in accordance with EU GMP Annex 1 Experience of New Production Introduction management Evidence of participating within an MHRA Regulatory inspection Experience managing a team / department Person Specification Qualifications / Professional Registration Essential Degree in relevant scientific discipline or equivalent experience. Master Qualification in a scientific discipline (preferably in Pharmaceutical Manufacture) or equivalent demonstrable experience. Eligible for Professional Registration e.g.General Pharmaceutical Council (GPhC), Health and Care Professions Council HCPC or Royal Society for Chemistry (RSC),Royal Society for Biology (RSB), Royal Pharmaceutical Society (RPS). Post graduate qualification in Pharmaceutical Validation / Quality Assurance or equivalent experience. Desirable Management qualification Professional Registration Experience and knowledge Essential Post qualification experience in Pharmaceutical Manufacturing, Pharmaceutical Quality Control or Quality Assurance. Experience of Quality Risk Management (QRM) and it's application in process design Extensive experience in the management and maintenance of pharmaceutical quality systems. Such as: Deviations, Change Control, Root Cause Analysis, CAPA, Quality Risk Management, Complaints, Recall, Supplier approval and management of outsourced activity. Evidence of continuing education/professional CPD. Detailed knowledge of MHRA Guidance on GxP Data Integrity Requirements, and evidence of application in a GMP environment Desirable Experience of computerised systems validation as per EU GMP Annex 11 Demonstrated experience of working in sterile manufacture in accordance with EU GMP Annex 1 Experience of New Production Introduction management Evidence of participating within an MHRA Regulatory inspection Experience managing a team / department Disclosure and Barring Service Check This 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. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). Additional information Disclosure and Barring Service Check This 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. Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab). From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab). Employer details Employer name Northumbria Healthcare NHS Foundation Trust Address Manufacturing and Innovation Hub Avenue Road Seaton Delaval NE25 0QJ Employer's website https://www.northumbria.nhs.uk/ (Opens in a new tab)