Chemistry Quality Control Laboratory Manager
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
- On-site nursery places via salary sacrifice
- Access to savings scheme via salary sacrifice with Northumberland Community Bank
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 Chemistry Quality Control 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. Initially, staff will be employed by Northumbria Healthcare Foundation NHS Trust, with employment transferring to the Medicines
Manufacturing Centre Legal Liability Partnership (LLP) upon its formation under TUPE regulations. 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.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.
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 medicines and advanced aseptic products.
Main duties of the job- Lead the implementation of strategies to build a robust, fit-for-purpose QC workforce for chemistry and physical testing.
- Line manage QC scientists, validation scientists, and physical testers.
- Ensure the QC chemistry and physical testing equipment is implemented, qualified, serviced, and managed, including overseeing outsourced work.
- Oversee new product introductions and production processes from a QC perspective.
- Lead validation scientists on method development, analytical method validation (ICH Q2), technology/method transfer, and QC stability testing (ICH Q1).
- Manage stability studies and ongoing stability testing, including national studies for NHSE/SPS.
- Lead QC Reference standards and oversee the testing of raw materials, consumables, packaging, and finished products.
- Manage QC testing in compliance with pharmacopoeia, environmental monitoring, temperature mapping, and cleaning validation for the MMC facility.
- Lead pharmaceutical quality systems, handling investigations, root cause analysis, quality risk assessments, and change controls.
- Monitor QC data recording/trending, KPIs, and data integrity.
- Collaborate with the QA department to ensure effective supplier approval and material testing oversight.
- Train QC chemistry lab staff and promote a culture of compassionate, inclusive leadership.
- Foster a collaborative, team-oriented environment with a focus on quality improvement and continuous learning.
Working for our organisation
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.
Funded with £30 million of investment from NHS England, the MMC will support a secure, sustainable supply chain for critical medicines, 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.
Detailed job description and main responsibilities
Job description attached separately
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. It’s more than a job—it’s a chance to contribute behind the scenes to better, safer healthcare for all.
Person specification
Qualifications
Essential criteria- Degree in relevant scientific discipline e.g. chemistry, pharmacy
- 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).
- Professional Registration
- Post graduate qualification in Analytical Chemistry / Pharmaceutical Analysis
- Post graduate qualification in Quality Assurance
- Management Qualification
Experience
Essential criteria- QC Professional requires detailed current knowledge of: MHRA Guide to Good Manufacturing Practice, and the British and European pharmacopeial requirements for raw materials, intermediates, and finished products.
- Post qualification experience in the analytical techniques used in pharmaceutical quality control.
- Knowledge in the qualification, use and maintenance of laboratory instruments including HPLC, FTIR, UV-VIS, pH, balances.
- Knowledge of analytical method development and analytical method validation (ICH Q2).
- Knowledge of developing stability studies as per ICH Q1.
- Experience of using Quality Management Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management.
- Knowledge in trending and statistical analysis of data.
- Knowledge of technical areas of pharmacy, including pharmaceutical manufacturing, procurement, auditing and unlicensed medicines.
- Experience in QC testing requirements of sterile medicines – both chemistry and microbiological specifications, in alignment with pharmacopeial requirements and formulation requirements.
- Experience in Microbiology QC testing e.g. environmental plates reading, Microorganism Identification techniques, media fertility testing, sterility testing
- 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
- Detailed knowledge of MHRA Guidance on GxP Data Integrity Requirements, and evidence of application in a GMP environment
- Experience of managing a team / department
Applicants who are members of the Armed Forces, and those who have a disability that requires support in the work place (two ticks pledge) and who meet the essential criteria will be interviewed under the Trust's interview guarantee scheme.
We recognise the positive value of diversity and inclusion and are committed to a workforce that is diverse, equal and inclusive. We welcome and encourage job applications from people of all backgrounds. We particularly welcome applications from Black, Asian and Minority Ethnic (BAME) candidates as BAME people are currently under-represented in our workforce as well as other under-represented groups such as LGBT+ and disabled candidates.We are proud to be a Disability Confident Employer, a Stonewall Diversity Champion, we have a Gold award from the Defense Recognition Scheme, and we are delighted to support Apprenticeships, Age Posi+ive and are a mindful employer.
If you require any reasonable adjustments to attend interview please make the recruitment team aware as soon as possible by calling our HR Recruitment Team on 0191 203 1415 option 2.
Applicants who meet the Fit and Proper Person Requirements (FPPR) will require additional pre-employment checks in line with CQC and NHS England statutory guidance.
Make sure to read the ‘applicant guidance notes’ before submitting your application and make sure you know everything there is to know before joining our fantastic trust!
Certificate of Sponsorship
Northumbria Healthcare NHS Foundation Trust proudly hold a sponsor licence. In order to provide sponsorship you and the role you are applying for must meet UKVI eligibility requirements. Please check your eligibility prior to submitting an application.Skilled Worker visa: Overview - GOV.UK (www.gov.uk)
Please note that it is a requirement of this Trust that all successful applicants pay for their own DBS certification if a DBS check is required for the post. The method of payment is a salary deduction from your first monthly pay.