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Clinical Supply Chain Operations Manager
2 months ago
Overview:
This role emphasizes the management of Import, Export, and Domestic bulk shipments across the EMEA and AMER regions.
Responsible for the timely and temperature-sensitive transportation of clinical supplies, ensuring punctual delivery.
Possess a comprehensive understanding of import and export regulations, procedures, and methodologies to enhance the execution of corporate goals.
As an expert in import and export logistics, assist in establishing distribution and return/destruction protocols for studies in accordance with logistics procedures.
Facilitate the onboarding training of new depot vendors as per business needs.
Contribute to the development of new systems while maintaining the logistics data and functionalities within existing frameworks.
Collaborate with internal teams to address logistics-related challenges, including QA, Finance, Tax, Procurement, Legal, and Regulatory Affairs.
Coordinate the application process for import and export permits as necessary and maintain records in e-Logistics.
Utilize IRT to monitor shipment statuses as required.
Ensure accurate and timely entry of logistics data and document uploads in BeiGene systems, adhering to established procedures.
Assist with BeiGene IOR and import tax deferral setups, managing IOR across various countries, providing approvals, and supporting related import VAT refunds as needed.
Conduct all duties in compliance with internal protocols and external regulations concerning import and export operations, bringing compliance issues to management's attention.
Work in tandem with QA counterparts to ensure audit preparedness and process control for all import and export activities, participating in logistics audits as required.
Support SCL during FDA inspections, internal audits, and external audits by preparing logistics data at the study or compound level.
Facilitate and coordinate with courier and depot vendors on all service aspects, including pre-conditioned shipping containers/materials, temperature data loggers, pickup appointments, expedited orders, and emergency deliveries.
Evaluate and report on the performance of Depot and Courier vendors, including metrics (KPIs) and any regulatory reporting obligations related to import and export activities to senior management.
Ensure smooth operation of cross-border movement requirements and business processes, identifying and managing issues/risks efficiently.
Establish deviations, corrective actions, and preventive measures in the BeiGene quality system (Veeva) for logistics incidents, collaborating with internal and external parties for timely investigation and resolution.
Thoroughly review all training materials, Work Instructions (WI), Standard Operating Procedures (SOP), and Global Standards (GS) to ensure complete understanding and alignment with job responsibilities.
Stay proactive in keeping abreast of the latest requirements and updates relevant to the role.
Schedule regular meetings with the 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 adherence to job standards and expectations.
Follow the Logistics team requirements, responding to urgent requests/GL approvals within 24 hours and replying to all emails within 2 working days.
Maximize productivity by utilizing company-provided tools and platforms, such as Outlook, OneNote, Excel, Smartsheet, Power BI, and eLogistics.
Consult with managers or process owners for clarification on uncertainties or for additional guidance, ensuring direct support and expertise are readily available.
Actively participate in training sessions offered by various functional teams to broaden knowledge and enhance skill sets across different organizational areas.
Complete assigned training related to Work Instructions (WI), Standard Operating Procedures (SOP), and Global Standards (GS) through the electronic Learning Management System and courses in BeiGene University.
Key Responsibilities:
Management of clinical import, export, and domestic bulk shipment activities.
Minimum of 5 years of experience in import & export logistics.
Bachelor's degree required.
Technical Skills:
Proficiency in Microsoft Office Suite.
Additional Qualifications:
None specified
Travel Requirements:
As necessary.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
