Manager, Cold Chain Clinical Supplies – Shire – Lexington, MA, USA
The Manager, Cold Chain role is responsible for providing the leadership and direction to Cold Chain Management and Lane Management for Clinical Supply group including driving improvements in the Cold Chain, ensuring adherence to GDP’s, GMP’s, harmonizing efforts globally, and identifying strategic solutions that will meet the business needs moving forward. In addition, this role is responsible for developing and supporting Supply Chain partners to oversee the management of cold chain responsibilities including training (3PL, CMO, Philanthropy partners). Furthermore, the Manager will oversee vendor management activities of our Cold Chain partners (day to day operations, QBR, metrics). The Manager, Cold Chain would be involved in further developing this technical capability at Shire and proposing what would be required to meet the future business needs.
Responsibilities:
100%:
• Responsible for identifying global and local solutions for controlling temperature sensitive products while in transit from the manufacturing sites through to final receipt by patient. The position will support Commercial, Clinical, and other functions as required.
• Maintain the ERP system with current approved shipping solutions.
• Create and implement Supply Chain SOP’s ensuring compliance with GDP’s, cGMP’s, and country specific regulations
• Manage and Direct Cold Chain Suppliers/vendors, day to day operations, Supplier Relations and invoicing
• Conduct and support audits of Cold Chain service providers and their internal processes.
• Oversee training of SC partners on how to execute the shipment to include cold chain, TempTales and Shipping Systems.
• Provide direction, leadership, and management to Supply Chain projects. Deliver projects on time and within budget.
• Actively manage and/or participate in Quality Systems related to the Cold Chain including deviations, investigations, CAPA’s, and Change Control.
• Evaluate current processes, identify, and implement improvement opportunities and implement business processes related to Cold Chain as required.
• Lane Management – ensure that lanes are appropriately established and maintained and adequately support/align with Cold Chain requirements.
• Lane Management- establishes new lanes that support/align with Cold Chain requirements for new market expansion.
• Responsible for assuring high value products reach their destination (our patients) in a safe, compliant, and cost efficient manner.
• Create and maintain metrics on Cold Chain operations
Education & Experience Requirements:
• 5+ years cGMP experience, preferably in cold chain distribution and finished goods management in both commercial and clinical environment
• 5+ years of experience executing cold chain validation and qualification activities
• Bachelor’s degree in related field
• 3+ years experience with International Cold Chain Shipments.
• Demonstrated understanding of supply chain management and logistics in a complex distribution environment
• Effective analytical skills with demonstrated success in problem solving
• Strong communication, organizational, and customer service skills
• Some travel is required (Domestic and International)
Key Skills, Abilities, and Competencies:
• Strong communication, organizational and customer service skills
• Self-motivated and energized in approach to work
• Ability to work in a fast paced environment with multiple priorities at multiple locations.
• Ability to build trust and form effective relationships with a wide range of both internal/external stakeholders as well as to share/communicate best practice.
• Ability to interact with internal departments
• Effective analytical skills with demonstrated success in problem solving
Shire’s Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.
