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BeiGene · 3 months ago

Senior Manager, Clinical Supply Chain, Logistics

United States

Full-time

Remote

Senior Level

$128K/yr - $173K/yr

7+ years exp

BeOne Medicines USA is a growing company focused on providing innovative solutions in the fight against cancer. They are seeking a Senior Manager for Clinical Supply Chain and Logistics to oversee depot storage, distribution, and drug destruction processes, ensuring compliance with internal and external regulations while managing vendor performance and logistics operations.

BiotechnologyHealth CareLife ScienceMedical

H1B Sponsor Likely

Responsibilities

Focusing mainly on the Depot storage, site distribution, drug return & destruction and logistics related Depot performance management in AMER regions

Work with Supply Chain Lead and depot PM setting up distribution and return/destruction procedures for studies following the logistics related procedures

Coordinate drug destruction at depot level regularly following BeOne internal procedure, ensure all certificate of destructions and executed disposition reports are archived and uploaded onto e-TMF accurately and timely

Well manage the depot monthly reports and implement regular stock-taking and reconciliation for depot storage as needed

Supports on 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 well maintain the logistics data and functions in existing system

Work with internal departments to deal with Logistics related issues as needed, for example, QA, Finance, Tax, Procurement, Legal and RA

Coordinate with external authorities to deal with Logistics issues as needed, for example, Customs and FDA

Coordinate internal or external functions for the Import and export permit application as needed

Understand how to use IRT to check shipment status as needed

Ensure the logistics data entry and documents uploading in BeOne systems could be performed accurately and timely as per BeOne related procedures

Support on BeOne IOR and import tax deferral setup, managing BeOne IOR in different countries, giving greenlight approval and supporting the corresponding import VAT refund as needed

Perform all responsibilities in compliance with internal procedures and external regulations related to import and export activities, brings compliance issues to the attention of management

Lead and measure processes to ensure logistics operations are completed with excellence on regular basis

Collaborate with QA counterparts to ensure audit readiness and process control for all import and 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 or compound level

Facilitate and coordinate with courier and depot vendors on all aspects of service, including pre-conditioned shipping containers/materials, temperature data loggers, pick up appointments, expedited orders and emergency delivery situations

Manage and assess Depot vendor’s performance and report Depot metrics (KPIs) to senior management

Ensure the requirements and business process associated with cross-border movements function smoothly, and issues and risks are identified and managed efficiently

Set up deviations, corrective action, and preventive action as necessary in BeOne quality system for logistics incidents, collaborate with internal and external parties to investigate the incident appropriately

Support and oversee daily and ongoing expenses to ensure that financial capital is used as efficiently as possible

Thoroughly review all training materials, Work Instructions (WI), Standard Operating Procedures (SOP), and Global Standard (GS) to ensure complete understanding and alignment with job requirements

Promptly review and respond in writing to all managerial directions. Consult with line manager in a timely manner if there are any questions or uncertainties

Remain vigilant and proactive in keeping up to date with the latest requirements and updates related to the role

Schedule regular meetings with line manager or function owners to ensure ongoing alignment and address any discrepancies or concerns

Evaluate the accuracy, thoroughness, and timely completion of assigned tasks, ensuring to meet the standards of job requirements and expectations

Follow the Logistics team requirement, respond to urgent request/GL approval within 24 hours, reply to all emails within 2 working days

Record and actively monitor the tasks/routine jobs with the target to meet all deadlines constantly

Maximize working productivity by leveraging company-provided tools and platforms, such as Outlook, OneNote, Excel, Smartsheet, and eLogistics

Consult with managers or process owners for clarification on any uncertainties or for additional guidance, ensuring direct support and expertise is readily available

Proactively participate in training sessions provided by various functional teams to broaden knowledge and enhance skill sets across different areas of the organization

Timely finish the assigned trainings associated with Work Instructions (WI), Standard Operating Procedures (SOP), and Global Standards (GS) through the electronic Learning Management System as well as the assigned courses in BeOne University

Perform other duties as assigned in a dynamic 'start-up' environment

Proficiency with Mandarin is highly preferred

Qualification

Clinical Supply Chain ManagementLogistics Performance ManagementRegulatory ComplianceData AnalysisVendor ManagementMicrosoft OfficeMandarinTeamworkCommunication SkillsInitiative

Required

Bachelor's degree or above and 7+ years of related experience is required

Proficiency with Microsoft Office