Senior Manager, Warehouse and Logistics – Alexion – Smithfield, RI, USA
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion is the global leader in complement inhibition and has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. In addition, Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). Alexion is advancing the most robust rare disease pipeline in the biotech industry with highly innovative product candidates in multiple therapeutic areas. More information about Alexion can be found at: www.alexion.com.
The Senior Manager, Warehouse and Logistics is directly responsible for the management of all operations related to the receipt, storage and shipment of materials and the associated cGMP procedures within North America Manufacturing. This leader will ensure all warehouses, internal or external, meet all cGMP standards, are inspection-ready at all times and personnel are properly trained to conduct their cGMP responsibilities. The Senior Manager, Warehouse and Logistics is responsible for cross-functional collaboration with other departments and functions that support clinical and commercial manufacturing.
Ensure delivery of goods and services; meet schedules and inventory stocking requirements.
Ensure supplies are monitored and production schedules are reviewed to determine both immediate and near-term material need.
Develop and deploy warehousing and transportation standards across the network.
Oversee management of spare parts inventory and kitting.
Identify and appropriately mitigate risks on both a site and network level, apply globally when necessary.
Develop and implement key performance metrics to measure performance and compliance.
Work with Global Procurement to organize quarterly business review meetings with key suppliers.
Create partnerships with key internal stakeholders and their organizations to ensure customer satisfaction.
Document, implement, and manage all policies and procedures as required by internal control and business requirements.
Foster professional development of direct reports.
Excellent interpersonal, written, and verbal communication skills, with demonstrated ability to effectively present complex technical details of supply chain processes to senior management, regulatory agency representatives, and external parties.
Experience leading warehousing activities in accordance with applicable procedures, corporate policies and cGMP requirements.
Manage movement of materials throughout the facility and across the network including receipt from suppliers/vendors, transfer in/out of quarantine, transfer of raw materials and disposables to manufacturing area, receipt of WIP and product from manufacturing.
Manage off site warehouses required for raw materials, disposables and bulk API product.
Maintains high level of inspection readiness in physical warehouse, procedures and documentation.
Ability to present and defend technical aspects of this role during regulatory agency inspections.
Ability to translate and capture the essential details of complex process information into clear, practical, and concise written and oral presentations.
Build high performing, engaged and effective teams through motivation and inspiration.
Build trust and collaboration by delivering exceptional service.
In depth knowledge of cGMP, GDP (Good Distribution Practices) and cold chain requirements as they relate to warehouse and transportation operations.
Experience using SAP (not sure what modules Alexion uses – example WMS)
Experience leading direct reports in cGMP warehouse and transportation operations.
Experience writing cGMP deviations, change controls and department SOPs.
Strong problem solving skillset.
Solid overall understanding of manufacturing and requirements for cGMP compliance.
Strong interpersonal and communication skills, with demonstrated ability to present effectively.
Must also understand manufacturing plant capabilities and have good project management skills to provide business planning in support of clinical and commercial manufacturing campaigns.
A minimum of ten years of warehousing and logistics experience in cGMP environments; at least six of those in a management role.
Prior experience working in a cGMP environment supporting manufacturing, utility and laboratories operations.
Technical undergraduate degree or equivalent experience.
APICS certification is a plus.
Learning and self-development
Manages ambiguity and complexity
Attracts and develops top talent
Optimizes work processes
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.