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 ground up. The role requires enthusiasm and competencies to 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.

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, country of origin of imported and exported manufacturing raw materials, finished drug product, intermediate drug substances, equipment, samples and related recordkeeping practices.

• Collaborating with other functions to get procedures implemented, test their effectiveness, delivering training to large groups of employees, identifying, quantifying, escalating, and mitigating 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, 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, 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 creation, management, and assignment of Trade compliance training content to global employees in Moderna’s Leaning Management System.

• Select, qualify, onboard, oversee and measure 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 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 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 Master Data Management team during new material introduction process in 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 (ACE portal), identify any irregularities and risk areas, audit information and implement corrective actions

• Create and maintain standard operating procedures for brokerage operations. Monitor and measure broker adherence to them.

Exporting procedures:

• Support daily outbound international shipping operations from Moderna’s manufacturing sites, contract manufacturing sites and 3rd party equipment manufactures.

• Determine if export shipments are subject to licensing requirements from the US Department of Commerce.

• Responsible for EEI (Electronic Export Information) filing compliance, including Moderna’s self-filings through customs ACE (Automated Commercial Environment) system and those submitted by freight forwarders and carriers.

• Conduct add-hock restricted party screening through Descartes application

Here’s What You’ll Bring to the Table:

Technical expertise:

• Certified Customs Specialist (C.C.S.) designation or Licensed Customs Broker (L.C.B.) required

• Regulatory knowledge of CFR19, FTR, EAR.

• Extensive experience writing comprehensive, well-constructed Standard Operating Procedures in English.

• In-depth understanding of the Harmonized Tariff System (HTS) and ability to properly classify commodities primarily in the United States, Canada. Proficiency in Chapters 29, 30, 39, 38, 84, 85 and 90.

• Thorough understanding of Routed Export Transactions

• Export controls (Deemed Exports, Sanctions, Anti-boycott, Restricted Party Screening)

• Export control classification process (ECCN#), export licensing determination process, Foreign Trade Regulations (FTR) and EEI (electronic Export Information) filing compliance

• Proficiency with SAP system, knowledge of SAP GTS; technology savvy

• 7+ years in various Trade Compliance roles (strong preference towards Pharmaceutical experience)

• Intermediate to advanced Microsoft Excel and Word knowledge (skillful in VLOOKUP’s and Pivot table functions)

• Project management skills with the ability to clearly articulate scope of a project, determine milestones, define stakeholders across multiple locations and departments, oversee progress, control risk, execute and close.  

• Education: University degree in supply chain, management/business administration

Personal qualities:

• Able to proactively build and maintain relationships within a global organization

• Incredibly agile, comfortable with a very fast pace, working well under pressure.

• Able to always keep a pulse on multiple priorities in parallel. Well organized and discipled to effectively manage, deliver results, and stay on top of all tasks.

• Ability to influence others – to inform, convince, and persuade others to action on key initiatives

• Good verbal and written communication skills to be able to explain compliance requirements and risks to stakeholders outside of trade compliance

• Ability to take initiative and work autonomously, as well as in a team

• Demonstrate a passion for knowledge and thirst for continuous improvement and learning

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary winter shut down 
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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