The Manager partners with Quality Assurance, Regulatory Affairs, Quality Control, Operations, Supply Chain, Procurement, Innovation and Development (InD), Analytical Research and Development (AR/D), Product Development, Commercial, and site leadership to support inspection readiness, supplier qualification and monitoring, compliance assessments, quality-system improvement, performance metrics, and timely escalation of significant risks. Partner with Quality Control, Regulatory Affairs, Supplier Quality, and Technical functions to ensure applicable compendial changes are evaluated, documented, implemented within required timelines, and escalated when gaps or delays are identified.