Senior Manager, Trade Compliance and Logistics *PC 809

Miltenyi Biotec; Gaithersburg (MD); On-site; USD 119,973 - 141,085; Full time

Job summary

Miltenyi Biotec North America is seeking a Sr. Manager, Trade Compliance & Logistics to lead the NA team and optimize international import/export operations for pharmaceutical products.

You will drive the development of a comprehensive trade program, ensure regulatory compliance with FDA, CBP, Health Canada, and other authorities, and partner with cross-functional teams to mitigate risks and improve supply chain performance.

Qualifications

• Bachelor’s degree in international business, supply chain management, logistics, law, or related field.
• 5+ years of leadership in international trade compliance or global logistics.
• Experience with regulatory compliance and cross-border operations.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead a trade compliance and logistics team across NA, ensuring compliant movement of pharmaceutical products.
• Develop and implement a comprehensive trade program aligned with global standards and local operations.
• Oversee import/export processes, license filings, and customs rulings with 3PLs and brokers.
• Monitor regulatory changes and advise leadership on impacts and policy updates.

Skills

leadership

project management

continuous learning

communication

cross-functional collaboration

Education

Bachelor’s degree in international business / logistics / law

Tools

SAP

ACE

Job description

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 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.

Coordinate efforts to meet and maintain high‑performance levels for import/export requirements, including monitoring & auditing daily import and export entry transactions in compliance with Customs. Resolve discrepancies, request corrective action with customs administrative entry submission as appropriate with support of 3PL, brokers, etc. Retain documentation.

Monitor and interpret changes in global trade laws, sanctions, and pharmaceutical‑specific regulations, advising leadership on potential impacts, and create 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. Lead 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 initiatives such as new product launches, commercial and clinical runs, CDMO, and distribution operations.

Drive operational efficiency: evaluate and implement customs simplification tools to enhance the cost‑effectiveness of global trade operations. Oversee daily import and export tasks, data entry, and invoice accuracy. Utilize KPI and scorecards to highlight operational opportunities and risks – propose and create 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: partner 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 leadership 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 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 application of Incoterms® 2020.
• Interpretation, understanding and application of regulatory requirements.
• Technical proficiency: strong working knowledge of SAP or similar ERP systems, ACE, etc.
• Classification mastery: advanced ability to determine Harmonized Tariff Schedule (HTS) codes and Export Control Classification Numbers (ECCN) for pharmaceutical, chemicals, machinery, equipment and parts thereof, and drug products.
• Organizational structure: working in a highly complex matrix organization. Ability to create and manage high‑performing teams of trade compliance and logistics professionals.
• Communication: exceptional verbal and written communication skills; ability to present complex regulatory requirements to executive leadership and government officials.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, sit, lift 35 lbs, and/or move. While performing the duties of this job, the employee is regularly required to use eye/hand/foot coordination.

Working Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in an office environment.

Salary and Benefits

The hiring range for this position is expected to fall between $119,973 and $141,085 per year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications. The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company’s good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Equal Opportunity Employer

Miltenyi Biotec North America is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

The Company will provide reasonable accommodations to candidates and employees, unless doing so would impose an undue hardship on the Company, in accordance with applicable law.