Senior Director, Quality Systems/QMS

Role: Senior Director, Global Quality Systems, leading strategic development and oversight of the enterprise-wide Quality Management System across GxP domains, products, modalities, and geographies. Responsibilities: provide strategic leadership to ensure the health, integrity, and effectiveness of QMS; align quality standards with global regulatory expectations; oversee risk management and continuous improvement initiatives; lead and develop Quality Systems Owners; champion quality culture and change management; collaborate with enterprise functions for compliance and inspection readiness. Requirements: BS/MS/PhD in Life Sciences or related field; 15+ years of relevant experience including 7+ years in leadership roles within global pharmaceutical or biotech organizations; extensive knowledge of GxP regulations, ICH guidelines, and regulatory interactions; proven track record in building and managing advanced Quality Systems and governance; strong stakeholder management, strategic influencing, and operational excellence skills. HighValue: senior leadership, global regulatory compliance, GxP oversight, cross-functional collaboration, change leadership, experience with clinical, CMC, or preclinical quality processes. WorkSetup: hybrid or on-site; travel up to 15%.