Job summary
An exciting opportunity has arisen for a proactive and passionate Quality Assurance Manager 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.
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
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
Act as the Quality Assurance (QA) Subject Matter Expert (SME), providing leadership to ensure all QA activities comply with GMP requirements.
Establish, implement, and manage Pharmaceutical Quality Systems (PQS) to support manufacturing operations and ensure robust quality oversight.
Oversee contamination control and environmental monitoring in collaboration with microbiology and cross-functional teams.
Lead QA involvement in batch release processes, including training and system setup.
Manage QA team operations, including resource planning, training, and performance.
Support site-wide quality culture by delivering training and promoting continuous improvement.
Ensure effective crisis management and QA oversight during planned and unplanned site events.
About us
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.
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 description
Job responsibilities
Provide expert QA leadership within the MMC, ensuring full compliance with GMP standards across all quality-related activities.
Design, implement, and maintain core PQS elements, including document control, change control, deviation management, CAPA (root cause analysis), risk management, complaints, recalls, supplier approval, and self-inspection programmes.
Establish and manage batch release systems, including review of Batch Manufacturing Records, label checks, QC data, and product inspection against specifications.
Lead the development and ongoing oversight of the Contamination Control Strategy (CCS) and environmental monitoring programme in collaboration with the Site Microbiologist.
Act as the lead trainer for QA processes, particularly batch release, ensuring effective knowledge transfer and compliance across the site.
Develop and manage QA capacity planning to ensure appropriate resourcing aligned with production demands.
Oversee QA involvement in site crisis management, including planned and unplanned shutdown activities, ensuring compliance and quality continuity.
Line manage the QA team (QA Officers and Releasing Officers), including performance management, coaching, and development.
Create and deliver structured training programmes for QA staff and provide QA systems training across the wider site.
Monitor and report on PQS performance through KPIs, trend analysis, and Quality Review Meetings, driving continuous improvement initiatives.
Promote a culture of inclusive and compassionate leadership by engaging, empowering, and coaching team members, and fostering collaboration across departments.
Job description
Job responsibilities
Provide expert QA leadership within the MMC, ensuring full compliance with GMP standards across all quality-related activities.
Design, implement, and maintain core PQS elements, including document control, change control, deviation management, CAPA (root cause analysis), risk management, complaints, recalls, supplier approval, and self-inspection programmes.
Establish and manage batch release systems, including review of Batch Manufacturing Records, label checks, QC data, and product inspection against specifications.
Lead the development and ongoing oversight of the Contamination Control Strategy (CCS) and environmental monitoring programme in collaboration with the Site Microbiologist.
Act as the lead trainer for QA processes, particularly batch release, ensuring effective knowledge transfer and compliance across the site.
Develop and manage QA capacity planning to ensure appropriate resourcing aligned with production demands.
Oversee QA involvement in site crisis management, including planned and unplanned shutdown activities, ensuring compliance and quality continuity.
Line manage the QA team (QA Officers and Releasing Officers), including performance management, coaching, and development.
Create and deliver structured training programmes for QA staff and provide QA systems training across the wider site.
Monitor and report on PQS performance through KPIs, trend analysis, and Quality Review Meetings, driving continuous improvement initiatives.
Promote a culture of inclusive and compassionate leadership by engaging, empowering, and coaching team members, and fostering collaboration across departments.
Person Specification
Qualifications
Essential
- Degree in relevant scientific discipline or equivalent experience.
- Masters / Diploma Qualification in a scientific (preferably in Pharmaceutical Manufacture) discipline or be willing to work towards a Diploma / Master's degree while in post.
- 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).
Desirable
- Management Qualification
- Professional Registration
Experience
Essential
- Post qualification experience in Pharmaceutical Manufacturing, Pharmaceutical Quality Control or Quality Assurance.
- Detailed working knowledge of EU GMP
- Knowledge of sterile manufacture in accordance with EU GMP annex 1.
- Knowledge and experience of product release.
- 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.
- Awareness of developments in technical areas of Pharmaceutical Manufacture.
- Evidence of continuing education/professional CPD
Desirable
- Demonstrated experience of working in sterile manufacture in accordance with EU GMP annex 1
- Awareness of policies and procedures which impinge on role
- Evidence of awareness of the NHSE Aseptic Transformation process.
- Evidence of participating within an MHRA Regulatory inspection
- Knowledge of or experience in coaching and mentoring practices and tools
- Knowledge of or experience in Quality improvement tools, techniques and methods
- Detailed knowledge of MHRA Guidance on GxP Data Integrity Requirements, and evidence of application in a GMP environment
- Experience of developing and executing systems for data integrity training to colleagues
- Experience of managing a team / department
Person Specification
Qualifications
Essential
- Degree in relevant scientific discipline or equivalent experience.
- Masters / Diploma Qualification in a scientific (preferably in Pharmaceutical Manufacture) discipline or be willing to work towards a Diploma / Master's degree while in post.
- 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).
Desirable
- Management Qualification
- Professional Registration
Experience
Essential
- Post qualification experience in Pharmaceutical Manufacturing, Pharmaceutical Quality Control or Quality Assurance.
- Detailed working knowledge of EU GMP
- Knowledge of sterile manufacture in accordance with EU GMP annex 1.
- Knowledge and experience of product release.
- 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.
- Awareness of developments in technical areas of Pharmaceutical Manufacture.
- Evidence of continuing education/professional CPD
Desirable
- Demonstrated experience of working in sterile manufacture in accordance with EU GMP annex 1
- Awareness of policies and procedures which impinge on role
- Evidence of awareness of the NHSE Aseptic Transformation process.
- Evidence of participating within an MHRA Regulatory inspection
- Knowledge of or experience in coaching and mentoring practices and tools
- Knowledge of or experience in Quality improvement tools, techniques and methods
- Detailed knowledge of MHRA Guidance on GxP Data Integrity Requirements, and evidence of application in a GMP environment
- Experience of developing and executing systems for data integrity training to colleagues
- Experience of 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.
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.
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).
