QMS Governance Manager

Key Skills:

Roles & Responsibilities:

• Lead and manage AGS QMS assessments for new activities, roles, and transitions.
• Provide guidance and solutions to functions and leaders during QMS assessments.
• Coordinate with AGS Center Management, Transitions team, and QMS Assessment team.
• Ensure compliance with AGS Activity Alignment Agreement (V-QMS-0118203).
• Plan, schedule, and execute site internal audits across AGS sites.
• Collaborate with functional leads to address audit findings and ensure timely CAPA implementation.
• Maintain audit readiness for external inspections and act as front/back room lead during audits.
• Monitor adherence to QMS processes including change control for AGS activities.
• Identify and proactively address process gaps or inconsistencies.
• Drive onboarding of new functions into AGS QMS governance.
• Provide QMS training and awareness programs within AGS centers as needed.
• Facilitate AGS QMS assessment meetings and act as liaison between managers and assessment team.
• Maintain and update Quality Activity Agreements (QAA), assessments, meeting minutes, and actions.
• Report QMS metrics and compliance status to leadership regularly.

Experience Requirement:

• 8 - 10 years of experience in Quality Management Systems, preferably in Healthcare/Pharma.
• Proven experience in internal audits, compliance, CAPA management, and QMS governance.
• Experience leading cross-functional quality initiatives and ensuring audit readiness.

Education: