• Oversee and execute global import and export activities in compliance with applicable trade regulations, including management of licenses, permits, and country-specific requirements. • Act as Importer of Record (IoR) when required, ensuring full compliance with statutory obligations and recordkeeping requirements. • Ensure internal procedures and broker practices remain aligned with evolving regulatory requirements. • Prepare, review, and maintain shipping documentation, ensuring inspection-ready archiving and recordkeeping. • Manage domestic and international logistics for cell banks, drug substance (DS), drug product (DP), and devices, ensuring timely and compliant delivery across the global clinical supply network. • Ensure real-time shipment visibility and timely resolution of logistics deviations, including delays, temperature excursions, and customs issues. • Establish, qualify, and maintain compliant logistics lanes, shipment models, and escalation pathways. • Build and manage a network of freight forwarders, couriers, and customs brokers, including sourcing, evaluation, selection, onboarding, and performance management. • Oversee GMP and Non-GMP inventory management, including tracking, reconciliation, and control across CMOs, depots, laboratories or other required sites. • Establish and oversee periodic inventory verification and review activities to ensure inventory accuracy, compliance and destruction as appropriate. • Investigate and resolve inventory discrepancies in partnership with Quality, CMOs, and internal partners. • Ensure logistics and inventory activities comply with GMP, GDP, GxP, and internal SOPs; support audits and regulatory inspections. • Partner with Quality on deviation investigations, root cause analysis, and CAPA implementation related to logistics, inventory, or trade compliance. • Perform Clinical Supply Chain activities, such as, but not limited to, study level forecasting and planning, packaging and labeling and/or finished goods distribution. • Develop and maintain SOPs, work instructions and reporting to support operational excellence and scalability. • Maintain Supply Chain Management metrics and KPIs to support internal reporting and external reporting for vendor oversight/governance