Job summary
- Main area
- Quality Assurance
- Grade
- NHS AfC: Band 8a
- Contract
- Permanent
- Hours
- Full time
- Flexible working
- Compressed hours
- Job ref
- 319-7883193JN
- Employer
- Northumbria Healthcare - NHCT Northumbria Healthcare NHS Foundation Trust
- Employer type
- NHS
- Site
- Northumbria Healthcare Manufacturing and Innovation Hub
- Town
- Seaton Delaval
- Salary
- £55,690 - £62,682 per annum
- Salary period
- Yearly
- Closing
- 13/04/2026 23:59
Employer heading
Quality Assurance Manager
NHS AfC: Band 8a
Do you want to work in one of the best performing NHS organisations in England? Work for an organisation that was voted the best acute and combined acute and community trust in the country, based on the experience of its staff (NHS Staff Survey 2022). Work in an organisation that supports its staff and focuses on staff experience as much as it does the experience of its patients? You can live and breathe in an area that has the cleanest air, cost effective living, great nightlife, some of the best schools with a wealth of history available on your doorstep. Sound too good to be true? Well it isn’t, this is what you get when you work for Northumbria Healthcare and, this is…the Northumbria Way!
What the Northumbria Way means for you:
- Extensive staff health and well-being programme including access to our specialist Wellbeing Hub
- Support and connection through a variety of Staff Network groups
- A range of flexible working opportunities
- Generous annual leave and pension scheme
- Access to lease car and home electronics scheme (qualifying criteria applies)
- Opportunities to improve your professional development through our vast training programmes
- Access to savings scheme via salary sacrifice with Northumberland Community Bank
We work closely with Kids First Nurseries that are based within our trust grounds at Wansbeck, North Tyneside and Hexham hospitals to care for our Trust family's children, they offer care for children from 6 weeks old up to 4 years. There are a number of funding options run by the government to help working parents, including Early Years Funding and Tax Free Childcare.
Flexible working offers choice in where, when, and how we work, ensuring patients remain at the heart of all we do. It’s open to everyone, and we aim to find solutions that work for both you and the organisation. All arrangements must be reasonable and balanced to maintain safe and effective patient care.
We are proud to be one of the country’s top performing NHS trusts – rated ‘outstanding’ overall by the Care Quality Commission (CQC). We provide a range of health and care services to support more than 500,000 people living in Northumberland and North Tyneside across the largest geographical area of any NHS Trust in England. Our teams deliver care from hospitals, a range of community venues and people’s homes. Our hospitals include a specialist emergency care hospital (the first of its kind in England), three general hospitals and community hospitals. In the community we deliver a wide range of community and public health services.
We lead in innovation and quality, having opened the Northumbria Healthcare Manufacturing and Innovation Hub during the Covid-19 pandemic and have recently launched our Community Promise – a pledge to make a real impact not just in healthcare but on the wider factors that affect people’s lives, such as education, employment and the economy.
If Northumbria Healthcare sounds like somewhere you could belong we would love to hear from you. Visit our website to catch up on our latest news.
Whilst Northumbria Healthcare are a highly innovative organisation, the use of Third Party Artificial Intelligence (AI) presents a risk to the integrity of our Recruitment & Selection processes. If you use AI, and it poses a risk to the integrity your individual recruitment process, we may withdraw your application at any stage of the process.
Job overview
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.
Working for our organisation
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.
Detailed job description and main 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 criteria
- 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 criteria
- Management Qualification
- Professional Registration
Experience
Essential criteria
- 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 criteria
- 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
Employer certification / accreditation badges
Documents to download
Further details / informal visits contact
- Name
- Carly McGurty
- Job title
- Deputy Head of Quality
- Email address
- [email protected]
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