Head of Quality Management Systems & Smart Release
Core
Own the global Quality Management System (QMS) and Smart Release for the Rare Disease Unit, driving risk-based, AI-supported review by exception and global process harmonization.
Role type
Senior leadership Quality Systems & Release transformation
Builds
Global QMS standards, Smart Release roadmap, and AI-enabled quality workflows
Domain
Biopharmaceuticals / Quality Management / AI
Deliverable
production ML models
Required skills
Global Quality leadership, QMS governance, CAPA, Change Control, Data Integrity, Risk Management, AI fluency, Process simplification, Team leadership
Preferred skills
Advanced degree, Inspection readiness, Matrix organization experience
Technologies
SAP Quality, AI/ML platforms
Responsibilities
Lead Smart Release vision and roadmap; Own global QMS processes (deviations, CAPA, change control); Advance Quality Management Maturity (ICH Q10/Q9); Build knowledge management and leading indicators; Redesign work for AI evidence gathering; Lead inspection and audit support; Develop global team of Quality Systems professionals
