Quality Assurance Compliance Manager

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom Blackfield Associates Full time
Quality Assurance Compliance Manager

Blackfield Associates is partnering with a leading biologics CDMO organisation in Cambridge to find a Quality Assurance Compliance Manager.

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

Key Responsibilities:

  • 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.

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