Associate Director – Trade Compliance & Import-Export Services, Foreign-Trade Zone Operations, Lilly Research Laboratories

Eli Lilly and Company • Us, IN

1d • Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and bringing life-changing medicines to those in need. Clinical Supply and Delivery (CSD) provides strategic planning, supply, and trial support services for global clinical trials. Lilly Research Laboratories Trade Compliance and Import-Export Services (LRL TCIES), a part of CSD, ensures U.S. import and export activities comply with U.S. Customs and Border Protection (CBP) and key Partner Government Agencies (PGAs) like the FDA, USDA, EPA, and USFWS. The Associate Director, TCIES & Foreign-Trade Zone (FTZ) Operations, LRL reports to the Senior Director – LRL Trade Compliance. This role is crucial for developing and executing strategies that enable compliant, efficient, and scalable global clinical supply operations. The position supports the expanded TCIES scope, including the activation of the Medicine Foundry Foreign-Trade Zone, addressing trade compliance needs at the Greenwood Innovation Center – Global Supply Logistics Solutions (GSLS), integrating trade compliance into the Enterprise Control Tower, and providing scalable support for Lilly acquisitions. As a subject matter expert in FTZ compliance, U.S. import/export operations, and trade compliance governance, this role offers day-to-day guidance and enhances audit-ready execution across TCIES. It bridges TCIES operations with broader governance and coordinates with various internal and external partners. Supervisory responsibilities may be assigned as organizational needs evolve.

Requirements

• Bachelor’s degree in supply chain management, international business, biology, chemistry, or a related field.
• 7+ years of progressive experience in U.S. import/export operations and trade compliance, including Foreign-Trade Zone administration and regulatory compliance.
• Experience in a regulated environment (e.g., pharmaceutical, life sciences, or similarly regulated industry) with strong documentation and audit-readiness expectations.
• Expertise in U.S. trade regulations, including CBP requirements, Harmonized Tariff Schedule (HTS) classification, customs valuation, and Partner Government Agency compliance (FDA, USDA, USFWS, EPA).
• Working knowledge of Foreign-Trade Zone regulations (19 CFR Part 146), including admissions, inventory control/recordkeeping, manufacturing determinations, privileged foreign and zone-restricted status, and weekly entry procedures.
• Strong analytical, communication, and interpersonal skills; ability to anticipate risk, solve problems, and partner effectively across functions.

Nice To Haves

• Licensed U.S. Customs Broker or NCBFAA Certified Customs Specialist (CCS).
• Master’s degree in international trade, supply chain, law, or a related discipline.
• Direct, hands-on experience administering or overseeing FTZ operations in a pharmaceutical or life sciences manufacturing environment.
• Experience supporting trade compliance aspects of mergers, acquisitions, or business integrations.
• Familiarity with Enterprise Control Tower platforms and their application to trade compliance monitoring and supply chain visibility.

Responsibilities

• Serve as the TCIES liaison for the Medicine Foundry FTZ; ensure import/export compliance with CBP, FDA, and other PGA requirements.
• Develop and maintain FTZ protocols (admissions, inventory controls, manufacturing determinations, privileged foreign and zone-restricted status elections, and weekly entry documentation) in coordination with U.S. Import Export Compliance (USIEC).
• Monitor FTZ regulatory changes; assess impacts, implement updates, and maintain audit readiness with the Senior Director – LRL Trade Compliance and USIEC.
• Advise on duty-deferral, duty-elimination, and inverted-tariff opportunities to support cost optimization.
• Provide subject matter expertise across LRL TCIES, including Harmonized Tariff Schedule (HTS) classification, customs valuation, country-of-origin marking, and PGA compliance for U.S. imports and exports.
• Assign FDA product codes, affirmations of compliance, and labeling requirements; maintain complete, audit-ready documentation for clinical and research materials.
• Resolve regulatory holds, customs delays, and shipment exceptions by coordinating with FDA, brokers, couriers, and logistics providers, with emphasis on time- or temperature-sensitive materials.
• Partner with Regulatory Affairs to ensure accurate Investigational New Drug (IND) data supporting compliant U.S. importation.
• Support customs valuation determinations and documentation, including World Trade Organization (WTO) valuation methodologies, as needed.
• Provide tailored trade compliance support for Global Supply Logistics Solutions (GSLS) operations within the Greenwood Innovation Center (GIC), embedding customs and regulatory requirements into global clinical supply logistics.
• Serve as the TCIES subject matter expert for trade compliance integration into the Enterprise Control Tower, strengthening real-time visibility, risk identification, escalation protocols, dashboards, and decision support across LRL supply chain operations.
• Support alignment of trade compliance policies across LRL, including export licensing, FTZ frameworks, and trade-sanctions protocols, in coordination with the Senior Director – LRL Trade Compliance and USIEC.
• Coordinate audits, reporting, regulatory filings, and compliance assessments; identify and remediate gaps to reduce regulatory exposure.
• Monitor U.S. and international regulatory developments and support continuous improvement to sustain LRL’s compliance posture.
• Support Lilly acquisition workstreams and integrations by incorporating incoming operations into TCIES frameworks with minimal disruption.
• Develop and enhance internal controls, tools, and standard operating procedures to support a robust trade compliance environment across LRL.
• Partner with external logistics providers, customs brokers, couriers, CMOs, and suppliers to ensure alignment, transparency, and risk mitigation.
• Provide training and mentoring to TCIES personnel on trade compliance fundamentals, FTZ requirements, HTS classification, and standard procedures to ensure consistent execution.

Benefits

• Eligibility for a company bonus (depending, in part, on company and individual performance).
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision and prescription drug benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees