Quality system manager

Complaint Management (CMS) Establish and maintain the Global Complaint Procedure, ensuring compliance with quality standards and regulatory requirements, and governing site-level complaint process adherence. Collect, analyze, and monitor compliance and performance metrics through Quality Management Reviews; lead global complaint trend reviews. Drive data analysis and reporting initiatives, delivering actionable insights and comprehensive updates to management. Lead initiatives to improve complaint process efficiency, transparency, and alignment across global teams. Actively participate in site and global complaint review meetings, providing improvement insights, driving follow-up actions, and ensuring timely closure. Document Management (DMS) and Learning Management (LMS) Develop, implement, and maintain a global document management system. Ensure all documents are managed and stored in compliance with regulatory requirements and company policies. Manage document lifecycle from creation, review, approval, distribution, and archiving. Develop, implement, and maintain a global learning management system for global quality documents Ensure all training programs are compliant with regulatory requirements and company policies. Oversee the creation, delivery, and tracking of training programs and materials. Continuously evaluate and improve document and learning management processes to enhance efficiency and compliance. Implement best practices and industry standards in document control and training management. Develop and deliver training programs for employees on document management and learning management processes and systems. Provide ongoing support to global teams regarding document and learning management queries and issues. Conduct regular audits of document and learning management processes to ensure compliance and identify areas for improvement. Work closely with cross-functional teams, including manufacturing quality, commercial quality, design quality and Regulatory Affairs, ensure document and learning management needs are met. Communicate document and learning management policies, procedures, and updates to all relevant stakeholders. Support project assigned Develop, implement, and maintain the Global Learning Management System (LMS) to support training on quality documents and procedures. Oversee the creation, delivery, tracking, and continuous improvement of training programs to ensure compliance with regulatory requirements. Provide ongoing support and training to global teams on document and learning management processes and tools. Projects & Continuous Improvement Execute assigned global and corporate projects with minimal supervision, ensuring timely delivery and alignment with business objectives. Continuously evaluate and enhance complaint, document, and learning management processes to improve efficiency, compliance, and global standardization. Serve as a subject matter expert (SME) by leading global CMS/DMS/LMS transformation and automation projects to drive process efficiency and innovation. Leadership & Strategy Manage a team of quality professionals, providing guidance, coaching, and support to achieve quality and business objectives. Apply in-depth business knowledge to align quality system strategies with organizational goals and regulatory expectations. Develop and foster strong relationships with key stakeholders across manufacturing, commercial and product business unit. Assure adherence to budgets, schedules, work plans, and performance requirements for all assigned projects and systems.