Teams at Otsuka America Pharmaceutical

Senior leader responsible for analytical development and QC strategies for small molecule drug substance and product across development and commercial lifecycle. Oversees method development/validation/transfer, QC operations (internal and external), regulatory submissions and inspections, CDMO/CRO oversight, and builds high-performing analytical teams to ensure cGMP compliance and data integrity.

This role leads data and AI engineering strategies for R&D, oversees a team of engineers, and ensures compliance with regulatory standards while fostering innovation and collaboration across functions.

Lead development and governance of RBQM frameworks across clinical trials. Drive risk assessment, mitigation, centralized monitoring, analytics-driven oversight, vendor alignment, regulatory inspection readiness, process improvement, and financial and people management to ensure compliant, efficient trial execution.