The role ensures digital quality systems, analytics platforms, and AI-enabled capabilities comply with applicable regulatory requirements, including FDA 21 CFR Part 820 / QMSR, ISO 13485, ISO 9001, EU MDR, emerging digital and AI requirements such as the EU AI Act, and global data integrity expectations, while supporting enterprise digital transformation and continuous improvement initiatives. The Senior Manager, Digital Quality Excellence is responsible for establishing and leading the enterprise digital quality strategy, ensuring Quality Management System (QMS) digital capabilities, data, and analytics enable proactive, insight-driven decision-making, sustained regulatory compliance, and operational excellence.