Senior Manager, Trade Compliance and Logistics

•PC 809 at Miltenyi Biotec Senior Manager, Trade Compliance and Logistics

•PC 809 at Miltenyi Biotec in Gaithersburg, Maryland Posted in 1 day ago.

Your Role:

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.

Essential Duties and Responsibilities:

Lead and develop 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 align 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 deploys 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, in which entails; to monitor & audit daily import and export entry transactions are in compliance with Customs, including, but not limited to resolve 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 interpret changes in global trade laws, sanctions, and pharmaceutical-specific regulations, advising leadership on potential impacts, creates 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 liaisonwith 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, andconduct regular internal reviews, risk assessments and audits to measure compliance levels. Identify potential risks or violations and implement corrective action plans.

Training:

?Create anddeliver 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 enhance the cost-effectiveness of global trade operations. Oversee daily import and export task, data entry, and invoice accuracy. Utilize KPI and score cards to highlight operational opportunities, risks - proposes and creates new metrics for the organization to make data driven decisions. Establish and monitor logistics KPIs including OTIF (On-Time In-Full), freight cost, etc. Foster a culture of accountability, safety, and operational excellence.

Logistics Strategy & Operations:

Own and execute logistics strategies aligned with business objectives and customer service goals. Oversee inbound, outbound, and reverse logistics processes. Optimize transportation networks, warehouse operations, and distribution performance. Drive continuous improvement initiatives to reduce cost, increase efficiency, and improve delivery performance. Use analytics and technology to identify operational improvements.

Supply Chain Collaboration:

Partners with warehouse, manufacturing, customer service, instrument services and inventory support, teams to ensure smooth product flow. Coordinate contingency planning for disruptions and peak periods. Develop risk mitigation plans for supply chain interruptions.

Requirements:

Bachelor's degree in international business, supply chain management, logistics, law, or a related field;

Experience:

?5+ years of experience in leadership with related fields in international trade compliance or global logistics, law, supply chain management Project Management, Continuous improvement Continuous Learning Credits in international trade, customs, export/import compliance, foreign trade, etc. Occasional Domestic & International Travel Knowledge / Skills /

Abilities:

Industry Knowledge :

? Proven expertise in the?pharmaceutical industry is highly preferred (Pharmaceutical, biotech, or medical device industry). Customs & Border Protection (CBP):?Proficiency in?

U.S. Customs?regulations, including 19 CFR, valuation, and the application of?

Incoterms® 2020. Interpretation, understanding and application of regulatory requirements

Technical Proficiency:

?Strong working knowledge