Director of Quality Assurance

The Director, Quality Assurance (QA) is responsible for leading the site Quality function within a GMP-regulated pharmaceutical manufacturing environment. The role ensures full regulatory compliance, product quality oversight, and continuous improvement of Quality Systems, while serving as the senior QA authority at site level.

Key Responsibilities

• Provide strategic and operational leadership for the QA department.
• Ensure compliance with cGMP, EU and US regulatory requirements.
• Oversee batch disposition and product release activities.
• Lead inspection readiness and act as primary QA contact during regulatory audits.
• Manage deviations, CAPAs, change controls, and risk management processes.
• Drive continuous improvement of the Quality Management System (QMS).
• Partner with Manufacturing, QC, Regulatory Affairs, and Supply Chain to ensure quality oversight across operations.
• Minimum 10 years e...

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