Director, Quality Systems

Role: Lead and oversee the company's Quality Systems, including document control and GxP training, ensuring compliance with cGMP and regulatory standards. Responsibilities: develop strategic roadmaps, manage and mentor teams, act as Business Process Owner of QMS, oversee compliance with FDA, EMA, ICH, and GxP requirements, and support inspection readiness. Drive continuous improvement, implement system updates, monitor performance metrics, and lead cross-functional quality projects. Qualifications: Bachelor's in life sciences with 12+ years in biopharma, including 7+ years leading Quality Systems; 5+ years of people management; expertise in QMS (CAPA, Change Control, Deviations, Risk Management), with Veeva Vault experience preferred. High-Value: extensive GxP experience, leadership in regulated biopharma environments, strategic planning, and global/regional compliance. Work Setup: not specified; likely hybrid/on-site given senior leadership nature.