Key Deliverables and Measures of Success: First 90 days: Complete a current-state map of priority PDE and QMS flows, quantify the most significant friction points, and align stakeholders on a prioritized simplification and AI opportunity roadmap. You will partner across R&D, Quality, Regulatory and other functions to reduce process burden, clarify ownership, improve alignment between PDE and the Quality Management System (QMS), and apply governed automation and artificial intelligence where they measurably improve speed, quality and compliance.