Strategic QMS Architecture & Modernization: Define, lead, and execute the QMS integration strategy for the lab transformation initiative, ensuring core quality processes (Change Control, OOS/OOE/OOT investigations, Deviations, CAPA, Method Transfer/Validation, and Batch Release support) are optimized, digitized, and natively integrated with automated laboratory systems. The QMS Quality Lead will oversee the harmonization and evolution of quality processes-including deviation management, investigations, CAPA, change control, risk management (ICH Q9), and computerized systems validation (CSV/CSA)-to ensure seamless integration with modern automated laboratory workflows, LIMS, ELN, and digital data pipelines.