Job summary
Head of Quality Control (QC) - Medicines Manufacturing Centre (MMC)
An exceptional opportunity has arisen to play a key leadership role in the Medicines Manufacturing Centre (MMC)--a state-of-the-art facility dedicated to producing sterile injectable medicinal products for the NHS. Based in Seaton Delaval, Northumberland, MMC will operate under MHRA Good Manufacturing Practice (GMP) standards, ensuring a secure supply chain for Systemic Anti-Cancer Therapy (SACT) products within the NHS for the next 10 years.
As Head of QC, you will lead both chemistry and microbiology activities within dedicated laboratories, ensuring the highest standards of compliance, safety, and quality. You will be responsible for building and leading the Quality Control team, overseeing the qualification of state-of-the-art analytical equipment, and implementing best-in-class QC procedures.
Why This Role Matters
At MMC, patients and quality are at the heart of everything we do. Our mission is to support NHS nurses and wards by delivering Ready-to-Administer (RtA) medicines, freeing up valuable time for direct patient care. By ensuring a stable and efficient supply chain of critical medicines, you will play a pivotal role in improving patient outcomes--working behind the scenes to make a real difference.
Main duties of the job
What You'll Be Doing
Shaping the future of NHS medicines manufacturing by influencing facility design and quality processes
Ensuring the highest quality standards in chemistry and microbiology testing for sterile injectable medicines
Recruiting and leading the QC team, fostering a culture of quality, safety, and innovation
Overseeing procurement and qualification of all QC equipment and systems
Developing and implementing a robust PQS (Pharmaceutical Quality System) to ensure compliance with GMP standards
About us
Working at MMC
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 once-in-a-career opportunity to help build a pioneering medicine manufacturing facility from the ground up. If you are passionate about pharmaceutical quality, innovation, and making a real impact on patient care, we want to hear from you.
Apply today and be part of something transformational.
Job description
Job responsibilities
- To provide leadership on all Quality Control (QC) related aspects within the MMC. This includes both Chemistry and Microbiology
- Implement QC policies which complies with Good Manufacturing Practice
- To lead in the creation of URS, tendering documentation and validation documentation for all chemistry and microbiology equipment
- To support the management of contractors and to lead on the commissioning and qualification of facilities and manufacturing equipment
- To lead on the implementation of a strategy to ensure a robust and fit for purpose QC workforce
- To perform QC Specialist functions as required including representation at national and regional level
- Manages the laboratory staff during day to day operations and longer term planning
Produces protocols and approves reports for stability studies, investigational work and validations
Leads on the implementation of stability studies, ongoing stability testing program investigational work and validations
Job description
Job responsibilities
- To provide leadership on all Quality Control (QC) related aspects within the MMC. This includes both Chemistry and Microbiology
- Implement QC policies which complies with Good Manufacturing Practice
- To lead in the creation of URS, tendering documentation and validation documentation for all chemistry and microbiology equipment
- To support the management of contractors and to lead on the commissioning and qualification of facilities and manufacturing equipment
- To lead on the implementation of a strategy to ensure a robust and fit for purpose QC workforce
- To perform QC Specialist functions as required including representation at national and regional level
- Manages the laboratory staff during day to day operations and longer term planning
Produces protocols and approves reports for stability studies, investigational work and validations
Leads on the implementation of stability studies, ongoing stability testing program investigational work and validations
Person Specification
Qualifications
Essential
- Degree in a scientific discipline e.g. Chemistry, Microbiology or Pharmacy
- Eligibility to register with a Professional Body for example: General Pharmaceutical Council (GPhC), the Health and Care Professions Council (HCPC), Royal Society for Chemistry (RSC) Royal Society for Biology (RSB) Royal Pharmaceutical Society (RPS)
- Evidence of continuing education/professional CPD
Desirable
- Post graduate qualification in Analytical Chemistry / Pharmaceutical Analysis
- Post graduate qualification in Quality Assurance
- Professional registration
- Management qualification
Experience
Essential
- Specialist QC Professional requires detailed current knowledge of: o MHRA Guide to Good Manufacturing Practice, and the British and European pharmacopeial requirements for raw materials, intermediates, and finished products.
- Significant post qualification experience in the analytical techniques used in pharmaceutical quality control
- Experience in QC testing requirements of sterile medicines - both chemistry and microbiological specifications, in alignment with pharmacopeial requirements and formulation requirements
- Experience in management of QC data integrity requirements and improvements
- Experience of using Quality Management Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management
Person Specification
Qualifications
Essential
- Degree in a scientific discipline e.g. Chemistry, Microbiology or Pharmacy
- Eligibility to register with a Professional Body for example: General Pharmaceutical Council (GPhC), the Health and Care Professions Council (HCPC), Royal Society for Chemistry (RSC) Royal Society for Biology (RSB) Royal Pharmaceutical Society (RPS)
- Evidence of continuing education/professional CPD
Desirable
- Post graduate qualification in Analytical Chemistry / Pharmaceutical Analysis
- Post graduate qualification in Quality Assurance
- Professional registration
- Management qualification
Experience
Essential
- Specialist QC Professional requires detailed current knowledge of: o MHRA Guide to Good Manufacturing Practice, and the British and European pharmacopeial requirements for raw materials, intermediates, and finished products.
- Significant post qualification experience in the analytical techniques used in pharmaceutical quality control
- Experience in QC testing requirements of sterile medicines - both chemistry and microbiological specifications, in alignment with pharmacopeial requirements and formulation requirements
- Experience in management of QC data integrity requirements and improvements
- Experience of using Quality Management Systems, including, leading out-of-specification investigation, root cause analysis tools, change controls, document management
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).
