Senior Director, Quality Management Systems & Compliance

Role: Senior Director of QMS and Digital Compliance at a biopharma focused on genome editing; responsible for leading quality assurance transformations to support regulatory compliance and commercialization. Key responsibilities include strategic planning for global QMS and digital systems, establishing governance frameworks, overseeing risk management and inspection readiness, and driving continuous improvement through analytics. The role emphasizes leadership in quality culture development, cross-functional collaboration, and external industry engagement. Requirements: 15+ years in pharma/biotech with extensive GxP, QMS expertise, and proven organizational transformation experience; deep knowledge of regulatory agencies (FDA, EMA); strong analytical, strategic, and leadership skills. Preferred qualifications include experience across multiple modalities (small molecule, cell and gene therapy), advanced data analytics proficiency, and a relevant advanced degree (BS, MS, or PhD) in science, engineering, pharmacy, or medicine. The position involves managing global teams, fostering a culture of quality excellence, and representing the organization in industry forums. Work setup: unspecified; no travel explicitly mentioned, but global scope implies potential cross-geography interactions.