Job Description

The QMS Governance Manager is responsible for providing centralized oversight and strategic direction for Quality Management System (QMS) governance within AGS. As the AGS organization expands in functional footprint and engages in increasingly regulated activities, this role ensures consistent application of QMS processes, proactive risk mitigation, and readiness for internal and external audits. The role plays a critical part in maintaining compliance with regulatory expectations, driving process integrity, and fostering a culture of quality across all operational areas in AGS sites
Major Accountabilities (Describe the main results of the job to be achieved )
AGS QMS Governance

• Lead and manage AGS QMS assessments for new activities, roles, and transitions.
• Provide guidance and potential solutions to functions and leaders during the QMS assessment process
• Coordinate with the AGS Center Management Team and Transitions team and AGS QMS Assessment team
• Ensure compliance to the AGS Activity Alignment Agreement (V-QMS-0118203).

Internal Audit Management

• Plan, schedule, and execute site internal audits across AGS sites.
• Collaborate with AGS Functional leads to understand audit findings and ensure timely CAPA (Corrective and Preventive Action) implementation and closure, as applicable.
• Maintain audit readiness for external inspections and serve as either the front or back room lead during audits.

Process Oversight & Change Control

• Monitor adherence to QMS processes including change control for AGS activities
• Identify and address process gaps or inconsistencies proactively.

Training & Awareness

• Drive onboarding of new functions into AGS QMS governance.
• Provide specific training on QMS related topics, as needed, such as QMS awareness programs within AGS centers

Stakeholder Collaboration

• Own the facilitation for AGS QMS assessment meetings
• Act as a liaison between AGS managers, remote managers, and the QMS assessment Team.
• Facilitate smooth transitions through AGS governance alignment

Documentation & Reporting

• Maintain and update Quality Activity Agreements (QAA), AGS QMS Assessments, meeting minutes and actions
• Provide regular reporting of QMS metrics and compliance status to leadership.
• Providing accurate audit reports and maintaining lists for ontime closure

Number of subordinates: No direct reports
Financial responsibility: (Budget, Cost, Sales, etc.) - Indirect
Decision Making: Medium to High
Impact on the organization : Medium to High
Ideal Background (State the minimum and desirable education and experience level)
Minimum Desirable Experience requirement:

• 10-15 years of experience in QMS with 4-6 years in GxP Operations Audit
• Has minimum of 3 years experience in Healthcare / Medical devices / Pharma industry
• Certified ISO13485 auditor
• L6S Green Belt certified. Black Belt certification is added advantage
• Experience with Health Authority or Notified Body Audits

Languages:

• Excellent English both spoken and written

Specific Professional Competencies:

• Industry knowledge (Shared Services/BPO industry and Pharma/Medical Device)
• Certifications - Lead Auditor / Internal auditor certifications
• Certifications - Lean Six Sigma Green Belt / Black belt
• Ability to influence without authority and collaborate across all levels
• Skilled analytical thinking, attention to detail and passionate about driving improvements
• Able to thrive in complex cross-functional projects/situations and drive issue resolution
• Demonstrate excellent Business acumen, project management, verbal and written communication skills
• Good at Stakeholder management
• MS Office proficiency, Minitab, Visio

ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

Skills Required