Coordinates Clinical Operations, CMC department, and/or manufacturer sites on any supply chain management related activities by providing solutions and managing risks;
Provides detailed supply prediction/demand planning;
Develops labeling and packaging design and planning;
Supports on comparator sourcing prediction and planning;
Overall monitors supply inventory against the planning/dispensing schedule to ensure no out-of-stock.
Coordinate with quality team on deviations/CAPA and Batch Record Review.
Manages external vendors to ensure the accurate delivery and other logistics arrangements, as well as documentation maintenance;
Manages internal/external depot/manufacturer site on logistics arrangement and cooperates on supply release and distribution at manufacturer/packaging site;
Review IRT specifications and support User Acceptance Testing (UAT) as well as oversee daily supply activities in IRT.
Support the process and system development and improvement of clinical supply chain.
职位要求：
Management, or similar education required, Supply Chain Management, and/or Management Science or equivalent filed is preferred;
Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, ICH/GDP, GCP, 21 CFR Part 11, and Annex 13);
Experience of operations and systems including replenishment planning, capacity analysis, manufacturing and distribution in either a clinical or commercial environment;
Has a working knowledge of clinical supply import/export regulation/policy, and clinical supply best practices, IRT systems, as well as experience working within a cGMP environment.
4-5 years progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, and industry.