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:
- 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.
