Associate Director of Customs and Trade Compliance

Otsuka

Princeton, NJ, USA

Full time

Jan 24

Full Job Description

At Otsuka our mission is to create new products for better health worldwide. Our purpose is to defy limitations so that others can too.


Vision through 2030: “We are the trusted team of product development, manufacturing and supply experts that collaborate with all our communities to produce innovative solutions and quality products for our customers and patients.”


Mission through 2030: “We turn dreams into realities by going above and beyond for our customers and patients - securely, compliantly and efficiently.”


In this newly created role, as an Associate Director of Customs and Trade Compliance you will be responsible for establishing a global customs program to ensure company compliance with US and international customs and trade regulatory agencies. You will lead the establishment, maintenance, education, and enforcement of trade compliance policies and procedures in cooperation with US teams and other regions around the globe bridging program expansion and best practices. You will be responsible for the compliant, expeditious and efficient flow of imports and exports. This role will drive continuous improvement, ensure scalability, and manage related systems and information in a GxP environment. The position will be the Otsuka SME on import and export trade compliance activities.

Job Summary

At Otsuka our mission is to create new products for better health worldwide. Our purpose is to defy limitations so that others can too.

In this newly created role, as an Associate Director of Customs and Trade Compliance you will be responsible for establishing a global customs program to ensure company compliance with US and international customs and trade regulatory agencies. You will lead the establishment, maintenance, education, and enforcement of trade compliance policies and procedures in cooperation with US teams and other regions around the globe bridging program expansion and best practices. You will be responsible for the compliant, expeditious and efficient flow of imports and exports. This role will drive continuous improvement, ensure scalability, and manage related systems and information in a GxP environment. The position will be the Otsuka SME on import and export trade compliance activities.

Job Description

  • Manages a small to mid-sized team with a focus on policy and strategy implementation.
  • Delivers operational results that directly influence the results for the department.
  • Problems and issues faced may be difficult and may require understanding of broader set of issues; draws from prior experience, analysis, and investigation to develop solutions.
  • Works to gain cooperation of others outside of own job area regarding policies, practices, and procedures.
  • May contribute to the workforce and staffing plans for area of responsibility.
  • Serves as a cultural ambassador within function.

Job Duties include, but are not limited to:

  • Design, implement, and maintain a global customs program, policies, procedures, and controls to ensure company-wide compliance in accordance with guidelines of the U.S. Customs and Border Protection (CBP) and other relevant agencies.
  • Design and implement a process to manage and recover VAT. Find opportunities for duty refunds and cost savings including but not limited to classification, valuation, trade programs, and duty drawback.
  • Evaluate current import/export practices to identify risks and gaps with trade compliance regulations.
  • Identify cross departmental resources and roles required to manage customs program (i.e. Regulatory, Tech Ops, Legal, R&D, Product Security, and others).
  • Leverage IT systems to establish compliance procedures and manage SAP S4/HANA utilization and data accuracy.
  • Develop a process to maintain trade classifications and country of origin determinations data.
  • Serve as SME on trade issues including, but not limited to, HTS classification, country of origin determination, valuation, denied parties, embargoed countries, duty and tax reduction programs and red flag issues.
  • Build and maintain trade compliance internal training program and mechanisms for awareness across departments and regions involved in international exchange of materials. Develop related work instructions and standard operating procedures.
  • Support commercial, clinical, R&D, and other areas on international material movements and facilitate customs releases by ensuring compliance with the requirements of customs authorities and other agencies that regulate imports and exports, including but not limited to CBP, FDA, USDA, CDC, BIS, Census, EPA, and F&W. Manage ACE and ITACS systems related to these movements.
  • Evaluate all new Government regulations and ensure that import and export activities remain in compliance with changes. As necessary, incorporate changes into day-to-day operations and standard operating procedures. Provide updates to management on opportunities and risk impacts.
  • Establish and manage compliance metrics for reporting and the monitoring of third-party providers such as customs brokers, freight forwarders, and others involved in the customs process.
  • Establish and perform regular internal import and export audits; assist in regulatory post entry audits; resolve discrepancies, request appropriate corrections, reconcile, or protest as appropriate; verify valuation methodology. Ensure recordkeeping practices.
  • Establish a continuous trade compliance improvement philosophy. Identify and lead improvement projects ensuring appropriate documentation and provide recommendations on cost avoidance, best practices, and resource efficiency.
  • Develop and manage implementation of plan to become CTPAT member.
  • Ability to analyze and interpret complex issues and data gathered from a variety of sources and, through effective decision-making and planning, deliver high-performing business solutions relative to trade compliance.
  • Interact effectively with multiple functional areas including management, supply chain, distribution, regulatory, packaging engineering, finance, IT and legal.
  • Collaborate with other regions to develop a global approach to customs and trade compliance and identify opportunities to standardize processes, reduce the risk of noncompliance and implement a scalable program.
  • Incorporate Otsuka culture and build a professional and positive cultural environment for teammates and colleagues.

SOP’s and Compliance

Manage supply chain SOPs and training curriculum to comply with GxP, company policies, and industry regulations.

Qualifications/Required

Knowledge/ Experience and Skills:

  • Extensive knowledge of the following areas:
  • US customs regulations preferably with products under FDA authority
  • Product HTS and ECCN classifications, valuation, and Country of Origin determinations for pharmaceutical products
  • Automated Commercial Environment (ACE) and Import Trade Auxiliary Communications System (ITACS)
  • Customs reconciliation process, royalties, true-ups, and assists preferred
  • Experience with the CBP CTPAT program
  • GxP principals
  • Free Trade Agreements, Foreign Trade Zones, and VAT mitigation/recovery strategies
  • Cold chain transport
  • International freight management preferably in Pharma environment
  • Government regulations
  • Regulatory & Compliance functions
  • Project Management
  • Levering experience in managing expectations with external partners which will include Customs Brokers, Customs Attorneys, among others
  • Proven leadership in developing new business processes and moving them to automated systems and implementation
  • Experience in developing procedures and providing education/workshops to others
  • Ability to work independently
  • Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals
  • A curious mindset that allows you to constantly learn and challenge the status quo
  • Ability to participate in meetings scheduled outside of normal working hours, with offshore colleagues and vendors.
  • Occasional travel (~20%) may be required

Educational Qualifications

  • Education: Bachelor’s Degree in Business or related field
  • Years’ Experience: 8-10
  • Technical Skills:
  • Technical and Manufacturing Operations in regulated environments
  • Supply Chain and Material Management
  • Metrics & Trend Analyses
  • IT systems & tools (ERP systems, Microsoft Project, Excel, PowerPoint, etc.)
  • Financial Analysis
  • Operations Effectiveness
  • Business Drivers such as Quality, Cost and Service
  • API & Dosage Forms
  • Management, and Leadership Skills: Negotiation, Influence without authority, Team Leadership, Networking
  • Communication Skills: Well Organized (thought, communication, work)
  • Cultural Experience: Dealing with ambiguity, curious mindset, adaptative, be a part of a multi-team approach
  • Industry Experience: Pharma, Med. Device, Food

Preferred

  • Master’s or advance degree in Business or related field
  • NCBFAA Certified Customs Specialist (CCS) and/or Certified US Import Compliance Officer (CUSICO) preferred
  • Participation in industry groups (e.g., ICPA, AAEI)

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Come discover more about Otsuka and our benefit offerings;

https://www.otsuka-us.com/careers-join-otsuka

.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Valid Proof of COVID-19 Vaccination or Accommodation

The COVID-19 Vaccination is mandatory for incoming new hires and employees. Uploading documentation with proof of full vaccination record or an Otsuka approved accommodation will be required during the pre-employment process as permitted by law. New hires must be fully vaccinated unless there is an approved accommodation prior to start date.

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website

https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External

.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at:

https://www.ic3.gov

, or your local authorities.

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