Associate Director, Clinical Quality Management

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario. The Associate Director, Clinical Quality Management will serve as a Holistic Risk-Based Quality Management (RBQM) to Lead to develop and implement proactive risk management strategies within Clinical Operations. This role will oversee risk identification, mitigation, and compliance with regulatory requirements while ensuring data-driven decision-making and continuous quality improvement. Collaborate cross-functionally to enhance trial oversight, vendor management, and inspection readiness. Provides support with SOP Management, Inspection Readiness and CAPAs.