• Supporting transition from legacy paper-based processes to a scalable and compliant Electronic Quality Management System (eQMS) • Ensuring Quality System supports all stages of drug development — from nonclinical development through clinical development, regulatory submission (IND, NDA/BLA), commercialization, and product lifecycle management • Ensuring compliance with applicable GxP requirements (GLP, GCP, GMP), applicable FDA and global regulatory expectations, and industry best practices • Supporting inspection readiness, regulatory submissions, vendor oversight, and fostering a culture of quality and compliance across the organization