Quality Manager (GxP / Distribution and Quality Europe)

About Our Client

• Prestigious biotech company
• Temporary 12 month contract with option to extend or go permanent.

Job Description

• Provide quality oversight of internal and external GxP operations and lead, coordinate, and troubleshoot quality investigations, ensuring thorough root cause analysis and implementation of appropriate CAPAs
• Take ownership of quality issues and drive them to full resolution in close collaboration with Supply Chain, Manufacturing, Clinical Operations, Regulatory Affairs, and other stakeholders
• Monitor and manage temperature excursions, deviations, and complaints in a timely and compliant manner
• Act as Subject Matter Expert (SME) for deviation management and change control processes
• Analyze and resolve quality and operational process anomalies, providing compliant and pragmatic solutions aligned with global and EU requirements
• Support audits and inspe...