Manager, AGS QMS Governance at Alcon

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, PharmaceuticalsIndustries

Requirements

10-15 years of experience in QMS with 4-6 years in GxP Operations Audit
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
Excellent English both spoken and written
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

Responsibilities

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)
Plan, schedule, and execute site internal audits across AGS sites
Collaborate with AGS Functional leads to understand audit findings and ensure timely CAPA implementation and closure, as applicable
Maintain audit readiness for external inspections and serve as either the front or back room lead during audits
Monitor adherence to QMS processes including change control for AGS activities
Identify and address process gaps or inconsistencies proactively
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
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
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
Provide accurate audit reports and maintaining lists for on-time closure

Skills

Key technologies and capabilities for this role

QMS GovernanceInternal AuditsCAPA ManagementChange ControlRisk MitigationRegulatory ComplianceProcess OversightStakeholder CollaborationTraining ProgramsAudit Readiness

Questions & Answers

Common questions about this position

What experience is required for the Manager, AGS QMS Governance role?

The role requires 10-15 years of experience in QMS with 4-6 years in GxP Operations Audit, at least 3 years in Healthcare/Medical devices/Pharma industry, Certified ISO13485 auditor, and L6S Green Belt certified (Black Belt is a plus). Excellent English skills both spoken and written are also needed.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

Does this role involve managing a team?

No, the role has no direct reports.

What makes a strong candidate for this QMS Governance Manager position?

Candidates with 10-15 years in QMS including 4-6 years in GxP Operations Audit, ISO13485 auditor certification, Lean Six Sigma Green Belt, and experience in healthcare/pharma industries with Health Authority audits will stand out.

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

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