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.
#J-18808-LjbffrDirector, Quality Systems in ca at Unknown Company
This position is listed as full time and hybrid.