Sr. 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 Sr. Director, Quality Assurance Compliance (Management Path) is primarily responsible for developing, implementing, managing and monitoring Alcon's global strategies for Corporate Quality Compliance programs and initiatives, for success and sustainability, both internally, as well as externally with Health Authorities.

Specifics include:

• Accountable in ensuring enterprise compliance to EU MDR 2017/745.
• Coach and develop both direct and as appropriate, indirect reports through ongoing, example-based performance feedback, and the provision of training and development opportunities.
• Strategically contributes to the development, articulation, implementation and continuous improvement of Global Quality, projects, policies and compliance programs.
• Communicate critical assessments to Senior Leadership regarding the state of compliance and quality so as to provide insights into risks or potential concerns (business, patient safety, etc.), and drive actions across the business to implement plans to improve compliance and quality performance.
• Supports in directing, administration and management of the Corporate Quality support for Health Authority  inspections by providing onsite manufacturing strategic pre-inspection preparatory support and provide strategic direction during Health Authority inspections.
• Contributes to negotiation of Alcon corrective action plans with Health Authorities (FDA, EMA, Competent Authorities, etc.) associated with inspectional observations so as to drive favorable Health Authority results.
• Supports in directing, administration and management of the Global Incident Management process (Escalation, Field Action Assessments, HA Reporting to include US Field Alert Reporting, Market Action, Compliance Alert, Compliance/Auditing Forums).
• Responsible for implementing the Global Market Action / Recall Management including cross functional risk assessment and input for global impact of internal and external notifications, product availability/replenishment, etc.
• Strategically contributes to external Health Authority submission management (FDA, EMA, Competent Authorities, etc.) for global statutory reporting, analysis of corrective actions, risk assessment, destruction and statutory termination activities of market action activities.
• Responsible for the creation, implementation and maintenance of all Alcon Computer Systems Validation standards and processes resulting in GxP-compliant, high quality IT solutions fit for their intended use.
• Drives strategic planning and operational execution for Data Integrity (DI) initiatives, including setting the direction, defining priorities, giving operational guidance, to ensure alignment of DI concepts according to standards and Health Authority regulations.
• All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

What you'll bring to Alcon:

• Bachelor’s Degree
• The ability to fluently read, write, understand and communicate in English
• 12 Years of Relevant Experience
• 8 Years of Demonstrated Leadership
• Location: Onsite
• Relocation Assistance/Sponsorship: None

Preferred Qualifications/Skills/Experience

• Degree in Chemistry, Pharmacy, Microbiology, Biology, Engineering or another related science
• Professional experience in regulatory affairs or quality management experience relating medical devices (to include EU requirements)
• Quality experience in medical device or pharmaceutical/related industry at senior level management functions. Aseptic Manufacturing experience strongly preferred.

How you can thrive at Alcon:

• Work together with colleagues to share standard methodologies and discoveries as work progresses.
• See your career like never before with focused growth and development opportunities.
• 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!

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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.com and let us know the nature of your request and your contact information.