Cold Chain & Transportation Manager – Shire – Lexington, MA, USA

Primary Role
• Manage all distribution lanes to ensure optimum costs while maintaining high customer service levels.
• Proactively manage all 3PLs and freight forwarders utilizing relevant KPIs.
• Work with cross functional groups to ensure that logistics shipping solutions are designed, developed and qualified to meet product requirements
• Understand industry best practices in temperature controlled shipping methods.
• Support Shire Global Trade Compliance initiatives and best business practices.
Responsibilities
50%
• Implement approved effective and cost efficient distribution capabilities incorporating industry best practices.
• Attend daily Customer Service Meetings to ensure weekly transportation schedule are met and all domestic and international shipments arrive on time and at temperature.
• Continuously analyze Shire transport lanes and recommend the correct 3PLs/Carriers for selection.
• Analyze and report transportation and distribution costs and monitor actuals against budgets.
• Ensure Shire products are transported & distributed in accordance with compliance with GDP’s, cGMP’s, and country specific regulations.
• Develop and maintain procedures, SOPs, standard forms, import/export compliance documentation, training materials, etc. in accordance with the principles/guidelines of Good Distribution Practice.
• Monitors and maintains SC Lane and Transportation database information and agreed KPIs.
• Create and maintain metrics on Cold Chain, transportation/Logistics operations.
• Minimize risk throughout the supply chain through effective communication with key stakeholders.
50%
• Responsible for assuring high value products reach their destination (our patients) on time in a safe, compliant, and cost efficient manner.
• Maintain the ERP system with current approved shipping solutions.
• Manage and execute shipping system and transportation lane studies to ensure compliance.
• Ensure shipping system performance qualifications (PQ’s) are planned and executed according to the project plan.
• Analyze the impact of new shipping systems assessing technical performance, operational efficiencies, sustainability and time to implementation.
• Responsible for working with International supply chain team to identify global shipping solutions for controlling temperature sensitive products while in transit from origin through final destination.
• Support design and route qualification, ambient temperature profile analysis, development of and associated protocols and reports for design development and qualification phases.
• Manage, track and confirm that all performance qualifications are documented and complete.
• SME on all Shire Shipping systems pack out configurations.
• Ability to navigate the Shire quality system, with responsibility for managing the timely reporting all deviations and CAPA’s.
• Responsible for organizing/scheduling vendor Quarterly Business Reviews, to include preparing agenda and PowerPoint/Excel presentations.
Education & Experience Requirements
• 10 years’ experience in a comparable position within the pharmaceutical industry
• Demonstrable knowledge of good distribution practices throughout the pharmaceutical industry
• Demonstrable knowledge of cold chain solutions and validation
• Project management skills demonstrable
• Knowledge of Global Trade Compliance measures
• Experience of working in an international environment
• Undergraduate degree in a relevant field
• Bachelor Degree
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