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. The Director, Quality Assurance Compliance (Professional Path), is primarily responsible for providing Global Quality Compliance direction to Business Unit(s), local sites, and others as needed to establish and implement practices and procedures that comply with applicable regulations, current industry and regulatory guidelines, and Alcon global standards.

Specifics Include:

• Coordinate and manage to close Field Action Assessments and market actions. Review escalations for immediate action and follow up.
• Provides compliance guidance to critical investigations (e.g., non-conformance, OOS, deviation, complaints, etc.) to ensure that issues or events are escalated as required, reporting requirements to regulatory authorities are met, and that investigation, analysis, corrective/preventive actions, and documentation are comprehensive and timely.
• Coordinate and review responses to Health Authority observations and queries/reporting regarding market actions.
• Coordinate Compliance Alert analysis with manufacturing sites and prepare Divisional summaries for approval and submission to Alcon.
• Prepare and present regulatory and Lessons Learned Information via Compliance Forums.
• Review and assess new / revised industry and regulatory standards for Division impact.

• Provide strategic expertise and direction, influencing multiple projects and overall business outcomes
• Lead Quality Systems Management, Complaints Management, and Supplier Quality Management processes to ensure compliance with current Good Manufacturing Practices (cGMP), Health Authority, Alcon Quality Manual, and International Organization for Standardization (ISO) standards
• Facilitate the implementation of the Quality Strategy and support governance processes
• Identify opportunities for improved process efficiencies and implement changes
• Define and report the performance of the Quality organization
  Own and maintain Quality systems
• Support Quality projects and strategic initiatives
• Make significant decisions within projects, requiring strategic planning and advanced industry knowledge

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
• Work Location: Onsite - 5 days per week in our Fort Worth office.
• Travel: <10%
• Relocation: Yes
• Sponsorship Assistance: No

Preferred Qualifications/Skills/Experience

• People and project management experience
• Experience in medical device or pharmaceutical industries
• Relevant work experience in a lab

How You Can Thrive at Alcon

• Work together with colleagues to share standard methodologies and discoveries as work progresses.
• Discover your career in a fresh way through specific growth and development possibilities.
• Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, 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.comand let us know the nature of your request and your contact information.