Quality Assurance Compliance Manager

Blackfield Associates is partnered with a leading biologics CDMO organisation based in Cambridge in the search for a Quality Assurance Compliance Manager.

As the Quality Assurance Compliance Manager, you will be responsible for overseeing risk management, change control processes, and non-conformance management within the company, ensuring compliance with both client expectations and regulatory standards (MHRA, HTA). This is a key leadership role, working within a dynamic and fast-growing environment focused on Advanced Therapy Medicinal Products (ATMPs).

Key responsibilities within the position include (but are not limited to):

1. Acting as the deputy to the Head of QA, providing leadership and guidance to the QA team.
2. Ensuring the company maintains a state of inspection readiness for audits and regulatory inspections (MHRA, HTA, and other authorities).
3. Leading internal and external audits, ensuring GxP compliance across all processes.
4. Overseeing change control processes, monitoring risks, and ensuring the prompt closure of quality records related to production.
5. Supporting cross-functional teams in identifying and implementing corrective actions and continuous improvement efforts.

The ideal candidate will have significant experience in a Quality Management role within a GMP-compliant environment, preferably in the cell and gene therapy sector. They should possess expertise in managing regulatory inspections, with a proven track record of leading internal and external audits. Strong leadership skills are essential, along with experience in managing and developing a team of quality professionals. A deep understanding of risk management, change control, and non-conformance processes within a Pharmaceutical Quality System (PQS) is required, along with a proactive, solution-driven mindset and excellent communication skills.

If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.