• Manage and continuously improve the Quality Management System, ensuring alignment with global regulatory requirements (e.g., FDA 21 CFR Parts 210/211, EU GMP, ICH Q10). • Oversee document management processes, ensuring timely creation, review, approval, and archiving of controlled documents (SOPs, policies, quality manuals). • Lead the deviation, investigation/audit, and corrective/preventive action (CAPA) processes to ensure timely closure and root cause identification. • Manage the change control system, ensuring changes are risk-assessed, justified, and properly implemented. • Coordinate internal audits; prepare for and support regulatory inspections; track and implement corrective actions. • Develop and monitor QMS performance metrics and quality KPIs; present trends and improvement plans to senior management. • Drive process improvement initiatives to enhance QMS efficiency and effectiveness using tools such as risk-based approaches and Agile methodology. • Partner with departments across organizations to ensure consistent implementation of quality standards and best practices.