Changes to manufacturing processes, technological innovations and altered supply chains require operational agility and can affect the availability of products required to meet patient needs. Manufacturers are expected to proactively manage quality and regulators to provide timely review of postapproval changes, but the current operating environment presents complexities and can pose challenges for both companies and regulators. In this keynote address, CDER’s Associate Director for Strategic Initiatives Theresa Mullin will discuss the current state of quality management, its challenges and international efforts to develop a global regulatory pharmaceutical quality knowledge management capability to enable greater regulatory reliance and enhance operational agility for both regulators and industry.