Senior Director, Head of Clinical Program Quality & Excellence (TAU)

Role: Senior Director, Head of Clinical Program Quality & Excellence (TAU), responsible for implementing risk-based quality strategies across clinical programs to enhance performance, regulatory confidence, and inspection readiness. Responsibilities include leading quality risk management, governance, investigations, inspection strategy, audit planning, and fostering a culture of quality and continuous improvement. The position involves strategic counsel to senior leadership and team development. Qualifications: Bachelor's degree in a scientific or health-related field; 12+ years in the pharmaceutical industry, with 5+ years supporting clinical development in quality or compliance roles. Deep expertise in GCP regulations, clinical trial quality systems, and risk-based quality management; experience with global inspections and remediation activities. High-value specifics: Focus on clinical development, GCP compliance, inspection readiness, risk management, and quality oversight in a global biopharma setting. Reports into VP, Clinical, Pharmacovigilance, and Medical Quality; based in Cambridge, MA, with full-time, exempt employment.