Manager, Trade Operations and Compliance

The Role:

In this role, the Manager of Trade Operations and Compliance will have an opportunity to contribute to the building of Moderna’s Global Trade Compliance program from the ground up. To succeed in this role, the individual must act with Moderna mindsets in mind in everything that they do: act with urgency, obsess over learning, behave like an owner, push past possible, and others. The person will handle a growing variety and complexities of operational responsibilities as well as supporting strategic initiatives, system implementations, process optimization, and integration of trade compliance requirements into other departments’ processes.  The Manager will be raising awareness about trade compliance, delivering training, and implementing internal controls to ensure compliance with US and Canadian customs (CBP and CBSA), Department of Commerce Bureau of Industry and Security (BIS), OFAC (Office of Foreign Assists Controls), CDC, USDA, FDA, and other governmental agencies. The focus of this position will be to support US and Canada operations.

Here’s What You’ll Do:

General Compliance and Initiatives:

• Developing and implementing internal trade compliance controls and procedures associated with the entry, classification, valuation, and country of origin of imported and exported manufacturing raw materials, finished drug products, intermediate drug substances, equipment, samples, and related recordkeeping practices.

• Developing and overseeing trade compliance processes for various business units and product types: Clinical product distribution for trials, commercial product distribution, manufacturing, etc.

• Collaborating with other functions to get procedures implemented, test their effectiveness, deliver training to large groups of employees, and identify, quantify, escalate, and mitigate compliance risks and gaps.

• Performing periodic checks necessary to determine the level of compliance, developing and conducting annual risk assessments to identify risks to compliance, and implementing corrective actions in response to errors and internal control weaknesses disclosed by self-testing.

• Collaborate with multiple internal and external stakeholders in the US and abroad, such as Planning, Procurement, Distribution and Logistics, Clinical Supplies, Supply Chain, Legal, Finance, Tax, HR, and Digital, to ensure that business processes within those departments account for trade compliance requirements.

• Oversee SAP GTS system implementation, including Restricted Party Screening, Export Controls, and Classification management.

• Act as a functional lead for onboarding new contract manufacturers, customers, vendors, and service providers.

• Periodically deliver training on trade compliance topics to internal stakeholders. Responsible for creating, managing, and assigning Trade compliance training content to global employees in Moderna’s Learning Management System.

• Select, qualify, onboard, oversee, and measure the performance of customs brokers.

• Advocate for trade compliance systems requirements.

• Apply the knowledge of all business processes touching trade compliance requirements (Order to cash process, Procure to Pay process, Plan to make process, Inventory to delivery process) during ERP system transformation initiatives. Advocate for Trade Compliance requirements and process automation in such areas.

• Partnering with digital teams in gathering trade compliance requirements, facilitating testing, rolling out new functionalities to the ERP system’s production environment, and handling post-implementation audit and process improvement.

Classification and Master Data:

• Facilitate creation, management, and maintenance of manufacturing raw materials’ trade master data in the SAP system, including Harmonized Tarif Classification (HS), Export control classifications (ECCN), and country of origin.

• Responsible for commercial raw material trade data integrity. Collaborate with planning, procurement, manufacturing, and quality teams to gather necessary information for raw material tariff determination.

• Supply HTS, ECCN classifications, and country of origin to the Master Data Management team during the new material introduction process in the SAP system.

Import Procedures:

• Ensure that Moderna’s customs brokers utilize the most current, verified, and documented tariff and country of origin data.

• Educate foreign vendors and contract manufacturers about US customs import documentation requirements. Create guidance documents, offer training, and escalate documentation issues that impact timely customs clearance to the materials planning group.

• Frequently generate reports from the customs system (