Associate Director - Quality Assurance Operations

Job Description

Scismic is supporting the continued growth of one of the largest healthcare manufacturing organizations in the world.

They are seeking an Associate Director for Quality Assurance Operations to join the team in Portsmouth, New Hampshire.

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
• Ensure 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
• Manages and tracks Key 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