Sr. Global Trade & Operations Compliance Specialist

Job Summary

The Senior Global Trade & Operations Compliance Specialist owns and drives end-to-end import/export trade compliance and global operations processes for the Puerto Rico market, supporting regulated supply chain activities across medical device, pharmaceutical, and biotechnology environments. The role serves as a site-level subject matter expert responsible for ensuring compliant, timely, and cost-effective movement of goods while aligning local business execution with Global Trade Controls Standards, U.S. Customs, FDA, export control, sanctions, embargo, and free trade agreement requirements. This senior role is expected to operate independently, come up to speed quickly, resolve complex shipment/documentation issues, influence cross-functional stakeholders, and proactively strengthen compliance, process governance, and operational readiness.

Job Details/Responsibilities

• Own end-to-end trade compliance business processes under Global Trade Controls Standards, including restricted/sanctioned party screening, export/import license management, HS/ECN classification, embargo screening, and FTA qualification.
• Lead import/export shipment compliance for Puerto Rico operations by partnering with freight forwarders, carriers, customs brokers, internal supply chain, QA, regulatory, finance, and commercial stakeholders.
• Review, critique, approve, and maintain import/export documentation, broker instructions, shipment records, valuation support, country of origin data, labeling inputs, and audit evidence.
• Analyze trade, logistics, and operational data from SAP, ERP, broker portals, and other corporate systems to monitor risks, identify trends, and support management reporting.
• Investigate and resolve complex trade compliance exceptions, shipment holds, documentation gaps, splintered responsibilities, adverse events, and broker/carrier escalations.
• Develop, update, and standardize local procedures, process controls, work instructions, KPIs, and training materials aligned to global standards and Puerto Rico site needs.
• Support continuous improvement, internal audits, corrective actions, and cross-functional readiness for regulated supply chain operations in medical device, pharma, and biotech environments.  Other related duties may be assign. 

Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

Knowledge

• Advanced knowledge of import/export regulations, restricted/sanctioned party screening, embargo controls, export/import licensing, HS classification, ECN/ECCN-related classification concepts, valuation, country of origin, FTA qualification, customs documentation, and recordkeeping.
• Strong understanding of U.S. Customs, FDA import requirements, export controls, global trade controls standards, broker management, and shipment documentation governance.
• Working knowledge of regulated supply chain operations within medical device, pharmaceutical, biotechnology, or other FDA-regulated manufacturing/distribution environments.
• Knowledge of manufacturing, warehouse, logistics, and customer fulfillment processes required to support compliant and timely movement of goods.

Skills

• Proficiency with SAP or equivalent ERP systems, Microsoft Excel, data analysis, reporting, and broker/carrier portals or trade compliance systems.
• Strong analytical, problem-solving, documentation review, and issue-resolution skills to assess compliance risks, shipment exceptions, data trends, and process gaps.
• Excellent bilingual communication skills preferred for Puerto Rico site execution, with the ability to communicate technical requirements clearly in English and Spanish.
• Effective stakeholder management, prioritization, organization, and process discipline skills to support audits, corrective actions, continuous improvement, and cross-functional execution.

Abilities

• Ability to apply trade compliance requirements within a manufacturing, warehouse, supply chain, and customer fulfillment environment while supporting business continuity and audit readiness.
• Ability to influence cross-functional stakeholders, provide technical guidance, support risk-based decisions, and coach peers or junior resources without direct people management responsibility.
• Ability to work independently with minimal supervision, exercise sound judgment, manage ambiguity, and escalate high-risk issues appropriately.
• Ability to perform physical activities that require considerable use of arms and legs and moving the whole body, such as climbing, lifting, balancing, walking, stooping, and handling materials.
• Capability to lift a minimum of 25 pounds, stand and walk for a long period of time, and handle and move objects by using hands and arms in handling, installing, positioning, moving materials, and manipulating things.

Unexpired Puerto Rico driver’s license, at least Category 3, is required since the position requires driving a motor vehicle as usual and integral part of the job.

Qualifications/ Background Experiences

• Bachelor’s degree preferred in International Trade, Supply Chain, Business Administration, Finance, Logistics, Compliance, Engineering, Life Sciences, or related field.
• 5+ years of progressive import/export, trade compliance, customs, global logistics, supply chain compliance, or regulated operations experience.
• Experience in medical device, pharma, biotech, FDA-regulated, or highly regulated manufacturing environment strongly preferred.
• Customs Broker License, Certified Customs Specialist, Export Compliance Certification, APICS/ASCM, or equivalent credential preferred.
• Demonstrated ability to independently manage complex trade compliance processes, cross-functional escalations, audits, broker interactions, and process improvements.

Fully bilingual, English and Spanish.