Remote RBQM Strategy Director

Otsuka America Pharmaceutical Inc. seeks an Associate Director of Risk Based Quality Management to develop and optimize RBQM frameworks across the clinical trial portfolio.

This senior leadership role partners with Clinical Management, Data Management, Biostatistics, and Safety to embed a data-driven oversight model aligning with global regulatory expectations (ICH E6(R3), E8(R1), FDA, EMA). The role leads the RBQM operating model, risk assessment, and analytics, driving continuous improvement,