• Develop, execute, and track remediation plans to address potential compliance gaps identified through due diligence, audits, or regulatory findings • Support remediation of legacy systems to meet compliance expectations • Partner with functions to lead remediation of Design History Files (DHFs), Technical Documentation, Risk Management Files, and labeling as required • Identifies critical path decisions, makes recommendations, and influences / gets buy-in from segment leadership and business process owners to maximize QMS integration, compliance and effectiveness • Provide clear communication of remediation status, risks, and timelines to leadership • Owns all project risk; including time and scope, and the associated plans to contain and/or mitigate risk • Coordinates Operational Reviews working across the organization to ensure targeted outcomes are achieved • Supports external and internal audit activity as needed