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Quality Assurance Manager Site Operations

1 month ago

Portsmouth, Virginia, United States Lonza Full time
Job Summary

The Quality Assurance Manager, Site Operations, is a key member of the site leadership team responsible for leading a team of QA Compliance/Operations Specialists. The successful candidate will provide general direction and support to QA staff and customers, ensuring objectives are met and expectations align with Lonza SOPs and regulatory requirements.

Key Responsibilities
  • Provide direction and support to QA staff and customers, acting as a point of escalation as needed.
  • Ensure objectives are met and expectations align with Lonza SOPs and regulatory requirements.
  • Partner with internal customers to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.
  • Review and approve documents, including SOPs, Work Instructions, Forms & Checklists, Scanned Documents, and electronic and/or paper Validation / Qualification documents.
  • Attend Change Control Committee, Deviations Review Board, and CAPA Board meetings as needed.
  • Manage and track Key Performance Indicating Quality Metrics, including batch release information for senior site management.
  • Identify and implement improvements to quality processes.
  • Provide general direction for the department, developing team goals, monitoring progress, and ensuring continuous improvement.
  • Conduct regularly scheduled 1 on 1 meetings with staff and team meetings to review objectives, provide support and feedback, and assistance resolving issues.
  • Participate in the hiring process, provide performance feedback, coach, mentor, and support career development.
  • Support Regulatory and Customer Audits as needed.

Qualifications
  • Bachelor's Degree with 3 years exposure to a GMP regulated environment.