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):
- Acting as the deputy to the Head of QA, providing leadership and guidance to the QA team.
- Ensuring the company maintains a state of inspection readiness for audits and regulatory inspections (MHRA, HTA, and other authorities).
- Leading internal and external audits, ensuring GxP compliance across all processes.
- Overseeing change control processes, monitoring risks, and ensuring the prompt closure of quality records related to production.
- 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.
