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Quality Assurance Director Operations
2 months ago
We are seeking a highly skilled and experienced Quality Assurance Director Operations to join our team at Lonza. This role will be responsible for ensuring that manufacturing-related GMP systems and controls meet global quality standards and applicable regulatory requirements.
Key Responsibilities- Lead the overall quality strategy within the asset
- Provide general direction and support to QA staff and customers
- Ensure objectives are met and expectations align with customer Quality Agreements, Lonza SOPs, and regulatory requirements
- Partner with internal customers to assess and resolve higher-risk issues with Change Controls, Deviations, CAPA, and Investigations
- Manage and track Key Performance Indicating Quality Metrics, including monthly/quarterly deviation trending reports for senior site management
- Perform Lot Release/Disposition activities
- Identify and implement improvements to quality processes
- Provide general direction for the department, develop team goals, monitor progress, and ensure continuous improvement
- Bachelor's Degree in a Science-related field
- 5+ years of experience