Sr. Manager, Quality Assurance Compliance

This role is part of Alcons Quality & Regulatory Affairs organization which ensures our products comply with global regional and internal regulatory requirements and consistently meet the highest standards of quality as we help people see brilliantly.

The Senior Manager Quality Assurance Compliance serves as a key Quality leader at the Irvine Technology Center (ITC) responsible for strengthening the sites quality systems compliance posture and audit readiness. This role partners closely with Manufacturing Engineering Supply Chain and Regulatory functions to ensure robust GxP compliance while enabling efficient scalable operations. The role also serves as the sites Deputy Person Responsible for Regulatory Compliance (Deputy PRRC) supporting EU MDR compliance obligations and acting on behalf of the PRRC as delegated and permitted. This is an onsite position based out of our Irvine-Alton Parkway location.

Key Responsibilities

• Lead and oversee site compliance activities across Quality Systems and Complaints processes to ensure alignment with current Good Manufacturing Practices (cGMP) Health Authority requirements and ISO standards.
• Proactively identify assess and escalate compliance and regulatory risks that may impact product conformity patient safety or regulatory standing.
• Drive audit readiness and execution including preparation for internal and Health Authority inspections; lead response development remediation plans and sustainable closure of audit findings.
• Act as a primary site interface during regulatory inspections and critical audits ensuring alignment consistency and accurate representation of site practices.
• Implement and sustain quality strategies and governance ensuring processes metrics and escalation mechanisms support both compliance and operational effectiveness.
• Identify and execute continuous improvement opportunities to increase process efficiency reduce compliance risk and simplify quality workflows without compromising standards.
• Provide compliance leadership and guidance on policies procedures and regulatory expectations; ensure effective training and adoption across the organization.
• Partner with crossfunctional leaders to proactively assess risk support investigations and ensure quality considerations are integrated into operational decisions.
• Lead develop and mentor teams making informed decisions that impact quality operations and site performance through strong leadership project management and communication.
• Ensure adherence to GxP expectations including proper execution of SOPs accurate and complete documentation and completion of required training.
• Serve as Deputy PRRC for ITC supporting PRRC responsibilities under EU MDR including oversight of quality system effectiveness compliance-related activities and escalation of regulatory risks as appropriate.

Key Requirements/Minimum Qualifications:

• Bachelors Degree or Equivalent years of directly related experience (or high school 15 yrs.; Assoc.11 yrs.; M.S.4 yrs.; PhD3 yrs.)
• The ability to fluently read write understand and communicate in English
• Relocation Assistance: Not Available
• Sponsorship Available: Not Available

Preferredrequirements:

• 10 Years of Relevant Experience
• 5 Years of Demonstrated Leadership
• Experience in Quality/Manufacturing/Operations/Engineering in Medical Device.
• Experience working in current Quality Management Systems (MES SAP Trackwise Teamcenter)

How to Thrive at Alcon:

• Join Alcons mission to provide outstanding innovative products and solutions to improve sight improve lives and grow your career!
• Collaborate with teammates to share standard processes and findings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Alcon provides robust benefits package including health life retirement flexible time off for exempt associates and much more!

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Alcons Total Rewards programs are designed to align to incentives with business goals encourage the right values and behaviors and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay which includes short-term incentives and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance supports savings for retirement promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcons Corporate Social Responsibility including our Total Rewards click here

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to 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 or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.