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 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 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:
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 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 35lbs, 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.
The hiring range for this position is expected to fall between $119,973- $151,692/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.
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.
Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry — our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.
