Provide Quality oversight for the qualification and validation of critical utilities and systems, including HVAC, WFI, purified water, clean steam, compressed gases, sterilizers/autoclaves, depyrogenation systems, filling equipment, BFS systems, PFS lines, IV Bag lines, CIP/SIP systems, isolators/RABS, environmental monitoring systems, and cold chain/storage systems, as applicable. Following commercial launch, maintain Quality oversight of routine sterile manufacturing operations, including continued process verification, sterility assurance, environmental and utility trend monitoring, deviation management, CAPA effectiveness, change control, periodic reviews, Product Quality Reviews (PQRs), inspection readiness, and continuous improvement to sustain a state of control.