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.
  
  
  

• 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.
  
  
  

• 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.
  
  
  

• 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.