COMPANY:
At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.
JOB SUMMARY:
The Director, Global Import Export Compliance is responsible for managing all Import, Export, and international trade activities globally for BioCryst. This includes the development, implementation and administration of global import export trade compliance policies and programs that drive accountability at all BioCryst locations for compliance with import requirements, export controls, and sanctions regulations. This position will work with all areas of the company including Commercial, RDMA, CMC, Clinical Supply Chain and Commercial Supply Chain. This role will oversee all import and export of investigational materials, raw materials, clinical trial materials, commercial WIP/finished goods and non-commercial goods/materials including payment of duties/taxes/VAT, and subsequent recovery of payments where regionally possible. Position has one (1) direct report: Manager, Logistics Operations. The individual should bring energy every day and work collaboratively to make hope a reality for patients suffering from rare and orphan diseases. #LI-Remote
ESSENTIAL DUTIES & RESPONSIBILITIES:
• Utilize International Trade Compliance expertise in a third-party manufacturing and distribution environment to lead a Global Logistics team managing import, export, and international trade activities globally.
• Support and function as a strategic advisor to senior leadership regarding the regulations that govern the international movement of goods, materials, and technology, specifically import requirements, export controls, and sanctions compliance.
• Manage entire logistics function including freight carrier management/contracts, warehouse/CMO logistics primary interface, movement tracking/trending, logistics metrics, and partnership with Procurement to ensure all logistics activity is identified/tracked with all suppliers.
• Oversee the strategic design, development, and implementation of a corporate logistics program including global trade, import/export compliance program, and general logistics movements of any materials.
• Communicate Trade Compliance policies to senior leaders and key stakeholders across the organization.
• Establish and administer a corporate-wide training program on import/export trade compliance and foster general awareness of trade compliance requirements throughout the organization.
• Develop, publish, and implement control documents (policies, procedures, processes, and work instructions) for Import and Export Operational activities.
• Provide daily guidance to all functions across BioCryst to ensure alignment and compliance with complex trade laws and regulations.
• Support relevant stakeholders with import and export classification, required import/export licenses, materials, technology, and services according to export controls and sanctions regulations. This includes Country of Origin, Tariff Code/Schedule B, Export Commerce Control Number (ECCN), FDA product codes, NDAs, INDs, customs valuations, duties/taxes/VAT for products imported/exported to support BioCryst projects.
• Develop and coordinate internal and external audits to ensure transactional compliance with established procedures, assess risk areas, and address and escalate gaps to mitigate corporate risk.
• Establish standards for record-keeping related to exports, licenses, and other trade compliance activities as well as acceptable document management for individual shipment documentation.
• Manage expedient addressing and resolution of any government related inquiries, requests for information, audits, and disclosures involving customs, export controls, and sanctions compliance.
• Initiate and oversee projects and controls that will drive further compliance with trade laws and regulations and mitigate risk globally.
• Set a global strategy to minimize duties with programs such as Trade Preference Programs, in-bond movements, and recovery of paid duties such as drawback
• Address trade related inquiries from customers, suppliers, and service providers (carriers, freight forwarders, 3PL, Customs Agents, Professional Service providers, etc.)
• Develop effective KPI measurable indicators for all aspects of import/export/transportation operational activities such as volume, type of entries, duties and transportation costs, and other available metrics.
• Perform all administrative function related to the logistics team (budgets, reviews, etc.)
EXPERIENCE & QUALIFICATIONS:
• Bachelor’s Degree (required), preferred in Business, Supply Chain/Logistics, or Science. An advanced degree, such as a Master of Business Administration (MBA) is preferred.
• Minimum 10 years of experience in Logistics/Distribution including 5 years of global import/export experience in the pharmaceutical or medical device industry.
• Strong understanding and experience with international trade compliance laws and regulations including but not limited to, imports, exports, economic sanctions, Harmonization Tariff system (HTS), country of origin, MSDS, Hazmat, boycott laws, and Free Trade Agreements.
• Working knowledge of trusted trader programs including Customs-Trade Partnership Against Terrorism (C-TPAT) and Importer Self-Assessment (ISA)
• BioCryst works with data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce.
• Strong analytical, mathematical, and critical thinking skills
• Demonstrated ability to be a collaborator and work effectively in cross functional team environment.
• Must have exceptional communication/presentation skills, initiative-taking, exposure, and/or knowledge of software programs including Microsoft Project, Interactive Response Technology (IRT), and Microsoft Office Suite. Advanced skills with Microsoft Excel are preferred.
• Experience with Supply Chain ERP/MRP systems such as Oracle or SAP. Experience with Quality systems such as Veeva is a big plus.
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability, and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state, and local law.
