Sr. Manager, Quality Assurance

Job description

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. Job Description (Specific responsibilities) • Promote a strong Quality Culture and awareness of regulatory and customer requirements throughout the affiliate/cluster. Drive awareness of the Quality System as a strategic platform for the business. Engage with the Leadership and functional teams to assure high standards of compliance to the regulatory and quality system requirements. • Engage, motivate and lead QA personnel through adequate training and effective communication, providing feedback to direct reports through one to one discussions, performance reviews, recognition and coaching. • Perform the duties as Quality Management Representative in country to ensure that a Quality Management System (QMS) is established, documented, implemented, maintained, reviewed and improved. This must occur in accordance with the currently published applicable Quality System Standards and regulations i.e. ISO/EN ISO 13485, EU Medical Device Regulation (if applicable) and duties as Responsible Person for wholesale storage and distribution according to GDP requirements (if applicable). • Ensure that products comply with market authorization and GMP requirements and are received, stored, handled, released, distributed and transported according to regulatory requirements including but not limited to ISO 13485, EU-MDR (if applicable to the region), GDP and relevant local requirements. Review documentation and approve incoming batches of medicinal products and /or medical devices, product returns and annual product quality reviews as required per local market. • Ensure that processes and procedures needed for an effective Quality System in are established, implemented, optimised and maintained, including but not limited to, self inspections, supplier qualifications and monitoring, CAPA process, management review, change control, risk management, Complaint handling, Quality Planning and SOP compliance. Initiate remediation activities as necessary, to ensure ongoing compliance. • Gather, maintain and report key quality indicators for the country/cluster, and promote process improvements through the use of lean methodology, self inspections, CAPA/non-conformance system and feedback process (complaints) • Lead audit preparation activities, facilitate, manage and close out external audits by Health Authorities and Notified bodies (if applicable to the affiliate), ensuring all corporate requirements are met and robust CAPAs implemented. • Manage and provide guidance to non conformance investigations ensuring formal structured approach to root cause analysis and problem solving, ensuring adequate corrective actions and prevention plans are implemented. • Ensure that all GxP suppliers are adequately qualified and monitored, and processes are compliant with Alcon Quality requirements (e.g. warehouse, distribution, redress/relabeling) and local regulations if applicable. • Ensure appropriate and timely escalation of quality events to management. Manage market actions (FSCAs, recalls, etc.) and report to the Health Authority in compliance with Corporate QA requirements and local regulations. • Ensure continual Quality System Compliance by adherence to established and evolving Alcon and regulatory requirements. 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. Note: For countries where specific elements of a role profile (such as Responsible Person and deputy) must align directly with local regulations, these may be captured in a supplementary role profile maintained in the local quality management system. Required Qualifications: BSc Degree in a Scientific or Engineering discipline or related field 5 years’ experience in the medical device or pharmaceutical industry 3 years of QA management experience including comprehensive knowledge of ISO13485 or similar 3 Years people management experience Any other specific local country qualification requirements must also be met ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker