Manager, Clinical Supply Chain
百济神州ShanghaiUpdate time: September 17,2019
Job Description
上海市
  • 招聘类型:社招
  • 工作性质:全职
  • 所属区域:Supply Chain & Logistics

职位描述

  • Performs all responsibilities in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
  • Implements solid transportation & storage relationships and distribution methods and protocols.
  • Executes temperature-controlled, on-time distribution of final drug product country/region-wide, ensuring on-time delivery and exemplary customer service. May also include coordination and shipment of Quality Control samples to external laboratories for analysis.
  • Facilitation and coordination with parcel carriers, couriers, and logistics brokers regarding all aspects of service, including shipping order placement, order tracking, pre-conditioned shipping containers/materials, temperature data loggers, white-glove service, pick up appointments and expedited order and emergency delivery situations.
  • Manages import and export of temperature-controlled materials to and from China as required, including processing the application for Import/export permits
  • Serves as direct liaison with Commercial Planning for distribution order management, transportation, delivery and problem resolution in support of the production schedule with internal and external manufacturing sites located in the region
  • Establishes operational procedures for activities such as verification of incoming and outgoing shipments, temperature data logging, and on-time/at-temp delivery performance.
  • Develops, implements and enforces SOPs for all aspects of logistics management, including import and export activities, transportation risk analysis and shipping validation for Finished Goods
  • Manages and assess courier vendor’s performance and reports operational metrics (KPIs) to senior management, as well as any regulatory reporting requirements related to transportation and logistics activities.
  • Lead the selection of courier vendor in order to determine optimal design and cost for regional/Affiliate logistics operations.
  • Leads and measures processes to ensure logistics operations are completed with excellence on a daily basis
  • Collaborates with corporate and facility-based QA and QC counterparts to ensure audit readiness, and process control for all logistics activities. Participates in regulatory audits
  • Coordinates with quality team on deviations/CAPA for incidents that occur during transportation
  • Support and oversee daily and ongoing expenses to ensure that financial capital is used as efficiently as possible.
  • Performs other duties as assigned, in a dynamic "start-up" environment.

任职条件

  • 5 8-10+ years progressive experience in Supply Chain within the biotech/pharmaceutical industry. A minimum of 3-5 years in a logistics management role for Commercial products, including import/export experience, lot-level inventory management and traceability, budget management, warehousing technologies, and temperature-controlled distribution protocols, in a regulated pharmaceutical/biotech environment
  • Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, 21 CFR Part 11, and Annex

13) and Knowledge of relevant commercial laws and regulatory guidelines.

  • Experience working in a global, complex supply chain organization within the biopharma industry.
  • Strong ability to collaborate and build strategic relationships with internal (Commercial, Quality, CMC, etc) as well as external (CMO, Couriers, etc) stakeholders
  • Experience in vendor oversight and managing external partnerships and relations
  • Experience with biologics (cold chain) and small molecule supply chain
  • Strong understanding of import/export requirements and customs practices
  • Experience in deviation investigation and CAPA implementation.
  • Ability to work effectively in cross-functional and multi-cultural teams
  • Good command of English in listening, writing, reading and speaking.
  • Demonstrated ability to work in a fast-paced team environment that requires quick turnaround and quality output, with minimal supervision and solid ability to multi-task across competing priorities to achieve success

职位要求

  • 学历要求:无
  • 工作经验:无
  • 外语要求:不需要

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