Senior Associate I, Quality Assurance Compliance

COMPANY OVERVIEW:
At Alcon, we are inspired by the meaningful work we do to help people see brilliantly. As the global leader in eye care, we boldly innovate, champion progress, and act with speed. We recognize and celebrate the contributions of our people, offering career opportunities that empower growth and fulfillment. Together, we go above and beyond to make a lasting impact on the lives of our patients and customers. We cultivate an inclusive culture and invite diverse, talented individuals to join us in shaping the future of eye care.

As a Senior Associate I, Quality Assurance Compliance (12 Months Contract), you will play a critical role in ensuring product quality through the effective maintenance of a robust Quality Management System (QMS). You will be responsible for driving compliance activities, conducting audits and supporting regulatory inspections within a manufacturing environment. This role requires close collaboration with cross-functional teams to ensure alignment with both internal procedures and external regulatory requirements, including GMP, ISO 13485 and MDSAP standards.

In this role, a typical day will include:
- Support the maintenance and continuous improvement of the site Quality Management System (QMS) in line with GMP, ISO 13485, and MDSAP requirements.- Prepare for and support external audits and inspections by regulatory authorities and notified bodies, including hosting responsibilities and follow-up on audit responses.- Ensure inspection readiness at all times by maintaining audit-compliant systems, documentation, and practices.- Lead the self-inspection program, including annual planning, execution, and trend analysis to drive continuous improvement.- Track and ensure timely closure of inspection-related commitments with comprehensive corrective and preventive actions.- Coordinate and complete the Annual Product Quality Review (APQR) with a focus on data integrity, timely reporting, and identifying improvement opportunities.- Oversee change management compliance, including review and approval of change records and impact assessments.- Analyze and monitor key quality metrics (e.g., deviations, CAPAs, change controls), identifying trends and proposing process enhancements.- Conduct gap assessments against corporate policies and regulatory standards to ensure continued alignment.- Partner with cross-functional teams to embed QMS best practices and promote a culture of quality and compliance.- Support regulatory submissions and documentation, including preparation and coordination of responses to authority queries.- Support product registration and license maintenance, ensuring timely updates related to regulatory filings.

WHAT YOU’LL BRING TO ALCON:
- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related discipline.- Minimum 5 years of experience in a pharmaceutical or medical device manufacturing environment, particularly in quality systems and regulatory compliance. Prior exposure to aseptic manufacturing is preferred.- Strong working knowledge of GMP, ISO 13485, and MDSAP frameworks.- Proficient in Microsoft Office and electronic quality management systems (TrackWise experience preferred).- Demonstrated experience supporting regulatory and notified body inspections.- High attention to detail with strong organizational, analytical, and communication skills.

HOW YOU CAN THRIVE AT ALCON:
At Alcon, we are committed to fostering a work environment where our employees can grow, innovate, and excel. Here’s how you can thrive in your role with us:
- Career Growth & Development - Gain access to continuous learning opportunities, leadership training, and career advancement programs to support your professional journey.- Collaborative Culture - Work alongside passionate and diverse teams in a dynamic and inclusive environment that encourages innovation and teamwork.- Impactful Work - Be part of a purpose-driven company that is improving lives by advancing eye care solutions worldwide.- Recognition & Rewards - Your contributions are valued and recognized through competitive compensation, performance incentives and career progression opportunities.- Global Exposure - Join a world-class organization with opportunities to collaborate across international teams and gain global industry insights.- Work-Life Balance & Well-Being - Enjoy employee wellness programs, flexible work arrangements and initiatives that support your well-being.

At Alcon, we empower our people to make a difference while growing their careers in an exciting and supportive environment. Join us and see brilliance in every opportunity

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