Supply Chain Manager
Ossium Healthcare, Inc.
Led Supply Chain support for a start-up site transitioning to clinical development in systems, process reengineering, inventory management, procurement, regulatory compliance, warehousing / logistics, organization development and facilities expansion. • Within the first 30 days redesigned planning systems and work-flow to eliminate material shortages and provide 100% material availability to internal customers. Key actions included corrections to planning logic, parameters, yield, demand / supply variability, supplier performance, process loss, identification of single sources, accuracy of Kanban replenishment cards, changes to daily workflows and use of visual systems.• Led site ERP project implementation in collaboration with corporate partners. Provided support in software provider selection, authored project charter, business requirements definition by stakeholder, detailed project plans, resource allocation, validation plans, design / modeling, training plans, data migration, and change management.• Addressed unsatisfactory states of cGMP compliance in the development supply chain related to CFR’s 210, 211, 1271. No observations were received during the site’s first critical inspection. Compliance upgrades included: numerous SOP revisions, design of a new warehouse facility to expected industry standards, creation of status designation labeling, training compliance, site ERP validation plans, change controls (warehouse qualification), protocols and elimination of documentation backlog (CAPA’s, investigations, Quality Notices for non-conformances, internal audit responses).