Director, Quality Assurance Compliance

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.

This role ensures alignment with global regulatory expectations (FDA, EMA, ISO), internal quality standards, and continuous improvement goals. The Director will serve as a key liaison with Contract Manufacturing Organizations (CMOs), lead complex investigations—particularly those involving chemistry and analytical methods—and foster a culture of proactive compliance and operational excellence. In this role, a typical day will include:

• CMO Oversight & External Partnerships
• Build and maintain strong, collaborative relationships with CMOs to ensure alignment with quality expectations and timely resolution of quality issues.
• Lead quality agreement negotiations and performance monitoring for external partners.
• Complex Investigations & Technical Depth
• Direct and support high-impact investigations, including those involving chemical processes, analytical testing, and contamination events.
• Serve as a subject matter expert in root cause analysis, CAPA development, and regulatory response strategies.
• Quality Systems & Compliance Leadership
• Oversee the Quality Management System (QMS), including change control, deviations, complaints, and audit readiness.
• Ensure compliance with cGMP, ISO standards, and internal policies through robust governance and risk-based decision-making.
• Continuous Improvement & Metrics
• Champion continuous improvement initiatives to enhance the site’s quality compliance posture.
• Monitor and report on key quality metrics (e.g., Right First Time, On-Time Batch Release, Deviation Closure Timeliness) and drive accountability across teams.
• Leadership in Ambiguity & Conflict Management
• Navigate complex, ambiguous situations with sound judgment and strategic foresight.
• Resolve conflicts constructively, fostering a culture of transparency, trust, and shared accountability.
• Cross-Functional Collaboration & Relationship Building
• Partner with Manufacturing, Engineering, Regulatory Affairs, and Supply Chain to ensure integrated quality oversight.
• Build and sustain strong internal networks to influence without authority and drive alignment on quality priorities.
  

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations .

WHAT YOU’LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
• The ability to fluently read, write, understand and communicate in English
• 10 Years of Relevant Experience
• 6 Years of Demonstrated Leadership
  
  

PREFERRED EXPERIENCE AND SKILLS:

• Extensive experience with FDA inspections
• Experience supporting Pharma and Medical Device product manufacturing
• Experience with complex global regulatory requirements for manufacturing
• Background in Chemistry
  
  

HOW YOU CAN THRIVE AT ALCON:

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

Alcon Careers

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, 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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.