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 goal
- Ensure compliance with quality standards and drive continuous improvement initiatives
- Manage departmental resources and make key decisions
- Guide non-conformance investigations with a structured approach to root cause analysis and problem-solving
- Lead audit preparation and manage external audits by Health Authorities and Notified Bodies
- Oversee all Quality-related activities at the country level, ensuring compliance with regulatory standards and global requirements
- Oversee quality control activities for finished products and handle product complaints
- Develop and oversee processes for an effective Quality System, includingself-inspections, supplier qualifications, corrective and preventive action (CAPA) processes, and Standard Operating Procedure (SOP) compliance
- Promote a strong Quality Culture and work closely with commercial partners and leadership teams to drive compliance as a strategic business platform
- Ensure compliance with market authorization, Good Manufacturing Practice(GMP), International Organization for Standardization (ISO) 13485, Good Distribution Practice (GDP), and local requirements
- Review and approve documentation for medicinal products and medical devices
- Ensure Good Practice (GxP) suppliers are qualified and monitored, and manage market actions
- Adhere to GxP regulations by following SOPs, maintaining accurate documentation, and completing required training
- Contribute to the overall compliance of the organization through individual job requirements
- Lead 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 function
- Oversees 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 continuity
- Oversee 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 requirements
- Drive 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 systems
- Lead 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 resolution
- Ensures 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 team
- This 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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