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 Leadership Team (QLT) (Management Path) is primarily responsible for leading the total quality function of a plant or group of plants, ensuring compliance with quality policies, Standard Operating Procedures (SOPs), and regulations. You will ensure the quality of materials, oversee training, and implement an effective Quality Management System. As the local Management Representative and ISO Deputy, you will ensure compliance with Quality System Standards and Regulations. Specifics include:
• Manage and direct Quality Assurance Departments, including Quality Systems, Documentation Control, Quality Control, Quality Engineering, Regulatory Affairs, Complaint Handling, and Laboratory Services
• Ensure compliance with European Union Medical Device Regulation (EU MDR) 2017/745 and meet experience requirements per Medical Device Coordination Group (MDCG) 2019-07
• Provide direction on quality systems and tools, focusing on process improvements
• Perform duties as Facility Management Representative to ensure effective Quality System implementation
• Maintain compliance with Food and Drug Administration (FDA) Quality System Regulations (QSRs), ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (MDR), and ISO 14000 standards
• Report on quality system performance and improvement needs
• Promote regulatory and customer requirements awareness throughout the organization
• Implement systems to prevent product recalls and manage postmarket surveillance actions
• Maintain responsibility for product sterility systems and product release
• Oversee product registration and maintain current registrations
• Manage a suitably resourced Quality Assurance Department with qualified personnel
• Promote cooperation and teamwork through open communication and coordination
• Identify potential successors for key positions and develop readiness plans
• Identify future budgetary requirements and manage Quality Assurance budget within targets
• Ensure Quality Management System compliance with Medical Device Single Audit Program (MDSAP) requirements and support certification efforts
• Adhere to Good Practice (GxP) regulations, maintain accurate documentation, and complete required training
• For Belgium, act as the Responsible Person for distribution activities in Puurs and Bornem warehouse, ensuring compliance with Benelux, European, United States, and other international 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.
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