Role Summary
Senior Manager, Clinical Supply Chain, Logistics responsible for depot storage, site distribution, drug return & destruction, and logistics performance management in AMER regions. Collaborates with Supply Chain Lead and depot PM to establish distribution and return/destruction procedures for studies, ensures compliance and audit readiness, and drives process excellence in logistics operations.
Responsibilities
- Focusing mainly on Depot storage, site distribution, drug return & destruction and depot performance management in AMER regions.
- Work with Supply Chain Lead and depot PM setting up distribution and return/destruction procedures for studies following logistics-related procedures.
- Coordinate drug destruction at depot level, ensure all certificates of destruction and disposition reports are archived and uploaded onto e-TMF accurately and timely.
- Manage depot monthly reports and implement regular stock-taking and reconciliation for depot storage as needed.
- Support Storage Insurance data calculation and reporting.
- Coordinate or directly organize site-to-site transfer shipments as needed.
- Arrange new depot vendor onboarding trainings per business requirement.
- Support on new system development and maintain logistics data and functions in existing system.
- Work with internal departments to deal with Logistics-related issues (QA, Finance, Tax, Procurement, Legal, RA).
- Coordinate with external authorities for Logistics issues (Customs, FDA).
- Coordinate internal or external functions for Import and export permit applications.
- Understand how to use IRT to check shipment status as needed.
- Ensure logistics data entry and document uploading in BeOne systems are accurate and timely per procedures.
- Support BeOne IOR and import tax deferral setup, managing BeOne IOR in different countries, greenlight approval, and supporting import VAT refunds as needed.
- Ensure compliance with internal procedures and external regulations regarding import/export activities; raise compliance issues to management.
- Lead and measure processes to ensure logistics operations are completed with excellence on a regular basis.
- Collaborate with QA to ensure audit readiness and process control for all import/export activities; participate in logistics audits as needed.
- Support SCL on FDA inspection, internal audit and external audit as needed on logistics data preparation per study/compound level.
- Coordinate with courier and depot vendors on service aspects (shipping containers, temperature loggers, pickups, expedited orders, emergencies).
- Manage and assess Depot vendors’ performance and report Depot metrics (KPIs) to senior management.
- Ensure cross-border movement requirements function smoothly; identify and manage issues and risks.
- Set up deviations, CAPA, and preventive actions in BeOne quality system for logistics incidents; investigate with internal/external parties.
- Support daily expenses to ensure efficient use of financial capital.
- Review training materials, WI, SOP, and GS for understanding and alignment with job requirements.
- Respond promptly to managerial directions; consult with line manager as needed.
- Stay up to date with latest requirements and updates related to the role.
- Schedule regular meetings with line manager or function owners for alignment.
- Evaluate task accuracy, thoroughness, and timeliness to meet job requirements.
- Follow Logistics team requirements; respond to urgent requests within 24 hours and emails within 2 working days.
- Record and monitor tasks to meet deadlines; maximize productivity using tools like Outlook, OneNote, Excel, Smartsheet, and eLogistics.
- Consult with managers or process owners for clarification or guidance; participate in cross-functional training.
- Complete trainings related to WI, SOP, and GS via LMS and BeOne University.
- Perform other duties as assigned in a dynamic startup environment.
- Proficiency with Mandarin is highly preferred.
Qualifications
- Education: Bachelor’s degree or above.
- Experience: 7+ years of related experience.
- Travel: As needed.
Skills
- Clinical storage, distribution, and return/destruction expertise.
- Logistics data management and system proficiency (BeOne systems, e-TMF).
- Regulatory compliance knowledge (import/export, FDA, customs).
- Vendor management and KPI reporting.
- Audit readiness and collaboration with QA.
- Cross-functional collaboration (QA, Finance, Tax, Procurement, Legal, RA).
- Problem solving, deviation/CAPA management, and process improvement.
- Mandarin language proficiency preferred.
Education
- Bachelor’s degree or above; 7+ years of related experience.
Additional Requirements