Senior Manager, Trade Compliance and Logistics *PC

Senior Manager, Trade Compliance and Logistics
* PC 809

Location:

Gaithersburg, MD, 1201 Clopper Road, Gaithersburg, MD 20878, USA

The Sr. Manager, Trade Compliance & Logistics is a strategic leadership role responsible for developing, leading the Trade Compliance & Logistics team, and continuously improving policies, procedures, and internal controls governing international import and export operations. As the primary trade compliance subject matter expert for North America, this role ensures adherence to U.S. and global trade regulations while optimizing logistics, mitigating supply chain risks, and supporting sustainable business growth.

As a global pharmaceutical innovator, we are dedicated to improving patient outcomes through breakthrough medicines and therapies. Safety, ethics, and compliance guide every shipment, sourcing decision, and partnership. We believe integrity in trade is as essential as innovation in science because patients around the world depend on us.

Lead and develop a team of trade compliance and logistics professionals responsible for supporting supply chain operations, ensuring adherence to international trade regulations while enabling efficient and compliant movement of pharmaceutical products and materials across North America, Canada, and other countries. Build high-performance teams through coaching, performance management, and succession planning.

Drive Program Development:
Develop, coordinate and implement a comprehensive trade compliance program that aligns with global corporate standard and local operations (Distribution, CDMO, Clinical trials, etc.) for North America. These programs should be tailored to pharmaceutical regulations including, but not limited to, FDA, DEA, CBP, USDA, CBSA, CDA, Health Canada, BIS, USTR, and other international equivalents. Imports are mostly from Germany to the United States.

Drive Regulatory/ Operational Oversight:
Oversee import/export applications, registrations and customs rulings and deploy changes to internal procedures based on these regulatory requirements. Maintain strict adherence to the Harmonized Tariff schedule classification, valuation, and country of origin guidance.

Manage, create, maintain and develop relationships with customs brokers, freight forwarders, carriers, third party logistics partners (3PL) and other related parties. Negotiate contracts, service level agreements (SLAs), and pricing structures. Evaluate vendor performance and implement corrective actions where needed.

Drive Coordination of efforts to meet and maintain high-performance levels for import/export requirements, monitoring & audit daily import and export entry transactions for compliance with Customs, including resolving discrepancies, requesting corrective action with customs administrative entry submission as appropriate with support of 3PL, brokers, etc. This also requires retention of documentation.

Monitors and interprets changes in global trade laws, sanctions, and pharmaceutical-specific regulations, advising leadership on potential impacts, creating policies, projects, etc. to implement changes regarding these new trade developments.

Government Liaison/ Cross-functional Liaison:
Manage relationships with customs authorities and partner government agencies. Serve as a liaison with supply chain, quality, legal and Regulatory Affairs to ensure timely and compliant product movement. Leads audits, requests for information, refunds, etc. for any external regulatory agency.

Audit &

Risk Management:

Create, coordinate, and conduct regular internal reviews, risk assessments and audits to measure compliance levels. Identify potential risks or violations and implement corrective action plans.

Training:
Create and deliver educational programs to site staff regarding trade compliance best practices, Restricted Party Screening, etc. Provide internal team guidance on trade compliance requirements on a case-by-case basis supporting initiative such as new product launches, commercial and Clinical runs, CDMO, and distribution operations.

Drives Operational Efficiency:
Evaluate and implement customs simplification tools to…