This position reports to the Transportation Ops NA Lead in Tech Ops and is responsible for coordinating cold chain and CRT shipments from 3PLs, Shire manufacturing plants, CMOs to international and domestic LOCs/Distribution Centers.
This position is responsible to coordinate the end-to-end transport activities and working closely with supply chain Logistics teams. Specifically responsible for coordinating shipments from CMOs, manufacturing sites, 3PL locations for replenishment and international and domestic shipments to LOCs/Distribution Centers.
This position is also responsible for creating global trade shipping documents for domestic and international shipments from origin to the final destination and performs relevant SAP/Global Trade transactions associated with each shipment.
This position focuses primarily on liaising with the Shire CMO organizations, 3PLs and Shire Plants in the US and Europe and execute the movement of product and product samples to meet timelines and deliverables. Responsibilities 60%: Transportation:
20%: Global Trade Compliance:
- Responsible for assessing the destination country regulations and the correlation to the export/import documentation: Commercial Invoice, Packing List, SLI, Certificate of Origin, Letter of Credit, Import Permits, Incoterms, etc.
- Coordinate with the Shire Planning team to meet all commercial and sample product deadlines / delivery request dates.
- Adhere to shire procedures, SOPs, standard forms, import/export compliance documentation, training materials, etc. in accordance with the principles/guidelines of Good Distribution Practice.
- Responsible for risk mitigation throughout the supply chain through effective communication with key internal stakeholders and Shire external partners.
- Ensure Shire products and samples are transported & distributed in accordance with compliance with GDP's, cGMP's, and country specific regulations.
- Assure high value products reach their destination on time in a compliant, and cost efficient manner.
In conjunction GTC and other key functions, ensure the development, management and adherence to the following compliance requirements:
- Import/Export compliance.
- Customs clearance and importation procedures.
- Origin determination.
- Customs Valuation.
- Service Level Agreements & Technical Quality Agreements.
- Compliance with GxP.
This position is responsible for Supporting Shire Global Trade Compliance initiatives and industry best business practices for temperature controlled shipping methods 20%: Cold Chain performance and qualification:
Education and Experience Requirements: Essential:
- Assist the Cold Chain Logistics and international leads with implementing shipping systems for Shire product samples.
- This position works closely with cross functional groups to ensure that logistics shipping solutions meet Shire validation requirements. A key element of this position is to identify and manage compliant cold chain transport solutions in a complex and high-regulated environment (cGMP, regulatory, trade compliance, costs, etc.).
- Support shipping system performance testing and transportation lane development for Non-Commercial shipments.
- Assist with the execution of shipping system qualifications (PQ's) according to the project plan.
- Work with International supply chain Logistics teams to identify global shipping solutions for controlling Non-Commercial temperature sensitive products while in transit from origin through final destination.
- Support Supply Chain Validation with route qualification and development of associated protocols for shipping system qualification phases.
Bachelor Degree and 2-4 years' experience in a comparable position within the pharmaceutical industry. Demonstrable knowledge of good distribution practices throughout the pharmaceutical industry. Knowledge of Global Trade Compliance requirements. Experience working in an international environment. Undergraduate degree in a relevant field. Desired:
Knowledge of Logistics, Supply Chain, Operations, Transportation, or International Trade Compliance preferred. Experience working in Pharmaceutical or highly regulated and compliance industry, cold chain temperature-controlled products. APICS Certification preferred. Other Requirements:
- Knowledge of cGMP manufacturing and end-to-end supply chain, as well as detailed knowledge in global logistics (transportation, warehouse, distribution).
- Knowledge of MS office tools (Outlook, Word, PPT, excel, access, project)
- Able to work in fast-moving environment.
- Domestic and International Travel up to 15%