Manager II- Quality Assurance

Promote a strong Quality Culture and awareness of regulatory and customer requirements throughout the affiliate. Drive awareness of the Quality System as a strategic platform for the business. Engage with the Leadership and functional teams to ensure high standards of compliance to quality system requirements.

Coach more junior QA team members and support activities related to assigning QA responsibilities and management of resources.

Work with QA leadership to 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/country) GDP and relevant local requirements. Review documentation and approve incoming batches of medicinal products and /or medical devices (as applicable per market) product returns and annual product quality reviews as required per local market.

Participate as needed in all activities required for an effective Quality Management including but not limited to self-inspections supplier qualifications and monitoring CAPA process management review change control risk management Quality Planning key performance indicators and SOP compliance.

Participate in audits of GxP suppliers and self-inspection program lead external audit preparation activities (as applicable) and contribute to external audits by Notified Bodies and Health Authorities as needed.

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 and distributors where applicable are adequately qualified and monitored and processes are compliant with Alcon Quality requirements (e.g. warehouse distribution redress/relabeling)

Raise awareness of QA risks as appropriate to QA management of affiliate and contribute to appropriate and timely escalation of quality events to management. Participate in the execution of market actions as needed.

Support initiatives to drive performance and ensure alignment with established KPIs resulting in consistent goal attainment and operational excellence.

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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