Manager, Ags Qms Governance

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