Executive Director, QMS & Digital

Role: Senior Quality leader responsible for strategy, governance, and continuous improvement of the company's Quality Management System (QMS) within a commercial-stage biopharmaceutical organization. Responsibilities: oversee core QMS processes (document control, CAPA, change control, deviations), establish governance and performance metrics, lead process excellence initiatives, and develop digital and data capabilities including AI and automation strategies. Provide leadership during regulatory inspections and audits, and ensure inspection readiness. Qualifications: 15+ years in life sciences Quality, including 8+ years GMP experience; expertise in QMS strategy, global GxP requirements, and regulated technology including CSV and data integrity. Experience in digital transformation, Quality analytics, and emerging AI governance. Leadership skills to develop teams and influence stakeholders; strong communication and strategic thinking. HighValue: extensive GMP and GxP knowledge, digital and AI strategy, regulated environment expertise, inspection readiness. WorkSetup: hybrid Waltham, MA; travel up to 20%.