At a Glance
- Tasks: Lead Quality Assurance, Control, and Validation in a fast-paced cell therapy manufacturing environment.
- Company: Specialist CDMO near Cambridge with a focus on innovative therapies.
- Benefits: Competitive salary, leadership role, and opportunity to shape quality standards.
- Other info: Join a dynamic team with a strong focus on operational excellence.
- Why this job: Make a significant impact in the evolving field of cell therapies.
- Qualifications: Significant ATMP experience and proven leadership in QA, QC, and Validation.
The predicted salary is between 80000 - 100000 £ per year.
We're partnering exclusively with a specialist CDMO based near Cambridge to appoint their next Head of Quality, the most senior Quality role in the business, reporting directly to the company President. The Quality leader will take full ownership of Quality Assurance, Quality Control and Validation across a licensed, GMP-regulated cell therapy manufacturing environment, overseeing a combined team of approximately 30 people across three functions. The organisation holds MIA, MIA(IMP), and HTA licences, operates Grade B cleanrooms, and manufactures autologous cell therapies at commercial and clinical scale. An MHRA inspection is anticipated in the near term. This is an operationally demanding environment that moves fast and expects its Quality leader to move with it.
The scope of the role:
- Full leadership of QA (11–12 staff), QC (12–13 staff) and Validation (5 staff)
- Named as person responsible for QC on the MHRA site licence
- Ownership of QMS, eQMS, contamination control strategy and inspection readiness
- Driving batch release, deviation management, CAPA, CCS and validation programmes
- Likely responsibility for a MasterControl eQMS implementation
- Key member of the site leadership team working alongside Operations and the President
What they're looking for:
- Significant ATMP experience - cell therapy strongly preferred, viral vector or advanced biologics considered
- Proven leadership of QA, QC and Validation together - not just one function
- Deep sterile manufacturing knowledge - Grade A/B cleanrooms, contamination control, CCS
- MHRA inspection experience, ideally in a licensed manufacturing environment
- MSc or PhD in a life sciences discipline preferred
- Commercial mindset - CDMO, commercial biotech or manufacturing-led organisation
Head of Quality - CDMO employer: AssureBio
This specialist CDMO near Cambridge offers an exceptional work environment for the Head of Quality, where you will lead a dedicated team in a fast-paced, GMP-regulated setting. With a strong focus on employee development and a culture that values innovation and collaboration, you will have the opportunity to make a significant impact on the quality of cutting-edge cell therapies. The company also provides competitive benefits and is committed to maintaining a supportive atmosphere that fosters professional growth and excellence.
