Director of Quality Assurance

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?

The Director, Quality Assurance is primarily responsible for developing and implementing strategies for quality oversight across all Affiliate sites within Alcon's Quality & Regulatory Affairs. You will ensure compliance with quality standards, manage quality events, and oversee complaint handling.

Specifics Include:Lead and direct teams to develop and implement strategies for departmental success and alignment with company goalEnsure compliance with quality standards and drive continuous improvement initiativesManage departmental resources and make key decisionsGuide non-conformance investigations with a structured approach to root cause analysis and problem-solvingLead audit preparation and manage external audits by Health Authorities and Notified BodiesOversee all Quality-related activities at the country level, ensuring compliance with regulatory standards and global requirementsOversee quality control activities for finished products and handle product complaintsDevelop and oversee processes for an effective Quality System, includingself-inspections, supplier qualifications, corrective and preventive action (CAPA) processes, and Standard Operating Procedure (SOP) compliancePromote a strong Quality Culture and work closely with commercial partners and leadership teams to drive compliance as a strategic business platformEnsure compliance with market authorization, Good Manufacturing Practice(GMP), International Organization for Standardization (ISO) 13485, Good Distribution Practice (GDP), and local requirementsReview and approve documentation for medicinal products and medical devicesEnsure Good Practice (GxP) suppliers are qualified and monitored, and manage market actionsAdhere to GxP regulations by following SOPs, maintaining accurate documentation, and completing required trainingContribute to the overall compliance of the organization through individual job requirementsLead quality reviews with leadership teams, oversee key quality indicators at both country and regional levels, ensure each country’s quality plans align with regional and global standards, and managing escalations to the Global Quality Compliance functionOversees monthly quality performance by tracking and submitting KQI metrics, managing quality risk assessments, preparing reports for the CSCQ Head, and maintaining ongoing surveillance to support business continuityOversee the end‑to‑end complaint handling operations, including timely intake, assessment, follow‑up, and routing of technical complaints and Adverse Events for all Alcon medical device products, ensuring compliance with local and international regulatory requirementsDrive a strong quality and compliance culture across the region by promoting best practices, ensuring consistent application of complaint handling processes, and supporting continuous improvement of quality systemsLead and develop the complaint handling team, providing guidance on investigations, overseeing case triage, and managing escalations such as product replacements and refund requests to ensure efficient and accurate resolutionEnsures strong people and capability development by driving talent development and succession planning, managing direct reports’ performance and compliance, overseeing training completion, and providing ongoing leadership and mentorship to the teamThis role also requires regular regional travel to support country teams, oversee activities, and ensure consistent implementation of quality standards

Education: Bachelor’s Degree in Life Sciences, Pharmacy, Engineering or other scientific discipline

Languages: English Proficiency Knowledge/ Fluency of at least one other language preferred

Experience:Minimum 15 years of experience in Quality Assurance, 10 years of people leadership in the medical device industry with people management experience in a matrix environment.Experience working in a multinational company or across multiple countries in the APAC region.Proven track record of developing and implementing quality assurance strategies and programs.Strong understanding of regulatory requirements and industry standards related to quality assurance (e.g., ISO 9001, ISO 13485, GMP, QSD and other industry standards that may apply).Excellent leadership and communication skills, with the ability to motivate and inspire teams to achieve quality objectives.Analytical mindset with strong problem-solving skills, able to lead root cause analysis and CAPA initiatives.Broad understanding of global expectations of Health Authorities in the GxP regulated area.Exposure to manufacturing operations and /or quality assurance, country organizations or commercial operations.Knowledge and experience in forecasting software and demonstrated proficiency in Microsoft suites.

Why join Alcon?- Join a global leader with a rich history of innovation and excellence in eye care.- Be part of a collaborative and supportive team culture that values diversity and inclusion.- Enjoy a competitive compensation package and opportunities for career advancement.- Make a meaningful difference in the lives of patients worldwide by contributing to cutting-edge advancements in eye health.

If you're ready to take the next step in your career and lead a dynamic team towards success, we want to hear from you! Apply now and join us in shaping the future of eye care at Alcon.

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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 any employment practices. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities.

If you need a reasonable accommodation for any part of the application process, please send an email to [email protected].