Teams at Otsuka America Pharmaceutical

Leads global R&D Quality across clinical, pharmacovigilance, and regulatory operations. Oversees inspection readiness, clinical and vendor audits, regulatory authority engagement, data integrity, quality systems, CAPA effectiveness, risk mitigation, management reviews, policy development, and departmental budgets. Builds and develops international QA teams while ensuring GCP, cGMP, QSR, and applicable regulatory compliance across development through commercialization.

Leads global supplier quality performance management for pharmaceutical and biopharmaceutical suppliers, CMOs, CDMOs, packaging vendors, and laboratories. Responsibilities include monitoring KPIs, maintaining dashboards, analyzing trends, presenting quality insights, coordinating risk-based supplier audits, managing quality agreements, and supporting deviations and CAPAs in TrackWise Digital. The role ensures supplier compliance with global GMP, GDP, GxP, and applicable regulatory requirements while partnering with Quality, Technical Operations, Supply Chain, and external suppliers.

Manages global supplier quality performance for pharmaceutical and biotechnology suppliers, including CMOs, CDMOs, laboratories, and packaging providers. Responsibilities include monitoring KPIs, developing dashboards and reports, supporting supplier audits and qualification, tracking CAPAs, maintaining Quality Agreements, assessing supplier risks, and managing supplier records in TrackWise Digital. The role collaborates with Quality, Technical Operations, Supply Chain, Regulatory Affairs, and external suppliers to maintain GMP, GDP, and regulatory compliance.