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Quality Assurance Director Operations

2 months ago


Portsmouth, New Hampshire, United States Lonza Full time
Job Summary

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
Qualifications
  • Bachelor's Degree in a Science-related field
  • 5+ years of experience