Head of Validation & Risk Management

Role Lead Takeda’s global process validation and risk management functions, establishing enterprise strategy, standards, and lifecycle practices across biologics, vaccines, plasma therapies, and synthetic molecules. Responsibilities develop and oversee validation frameworks for process design, PPQ, CPV, revalidation, cleaning, sterilization, and aseptic processes. serve as senior validation technical authority during inspections and regulatory interactions. build and manage a global team of validation SMEs. define standards, methodologies, and risk management practices. collaborate with manufacturing, R&D, CMC, quality, regulatory, and engineering functions to embed validation into product lifecycle. modernize validation approaches through digital tools and advanced analytics. and report on KPIs to senior leadership.