Quality Assurance Manager

QA Manager

Greater Manchester

SRG is currently working exclusively with a highly successful & award winning, CDMO based in Greater Manchester. Growing rapidly, the business specialises in taking products from discovery, all the way through early-stage trials, and to approval. They are now looking for a QA Manager to lead a small team and oversee quality, safety and efficacy standards at their new GMP facility.

The role:

In this role, you will lead and manage the Quality Assurance team at a GMP Manufacturing site in Greater Manchester. Key responsibilities will include:

• Leading the QA team and supporting other departments to maintain a culture of quality.
• Manage the QMS and processes, ensuring full compliance with GMP, regulatory & customer expectations.
• Support batch release activities by the QP.
• Lead the Investigations of deviations, complaints and OOS to prevent future non-conformance, implementing effective CAPAs.
• Lead internal audits and support site audit readiness.
• Support external / regulatory inspections.
• Approval and management of outside suppliers.
• Support ongoing training and continuous improvement activities.

Requirements:

• A degree or equivalent qualification in a relevant scientific field.
• Proven experience in a supervisory or leadership Quality assurance position in a GMP environment.
• Previous experience in analytical or GMP production environments.
• Experience of Early-stage produce development, or IMPs would be advantageous.
• Excellent knowledge of GMP requirements & compliance