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AD QA Ops
2 months ago
Leads the overall quality strategy within the asset
.• Provides general direction and support and acts as a point of escalation for QA staff and customers
.• Ensures objectives are met and expectations align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.
• Partners with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and Supply Chain) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.
• Attends and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings.
• Attends Site Quality Council and Lot Disposition meetings
.• Managesand tracksKey Performance Indicating Quality Metrics including monthly/quarterly deviation trending reports for senior site management. Performs Lot Release/Disposition activities
.• Identifies and implements improvements to quality processes.
• Provides general direction for department. Develops team goals, monitors progress and ensures continuous improvement.