Associate Director/Director, Logistics and Trade Compliance
The Associate Director/Director, Logistics and Trade Compliance is responsible for overall strategy, operational leadership and compliant movement of cell and gene therapy materials in support of Beam’s R&D, Clinical and Commercial (future) portfolio. This role will report to VP of Supply Chain, Technical Operations.
Trade Compliance - risk leader for the entire organization and, as such, is required to have strong technical expertise in international, federal, and state laws and regulations related to import-export and permits. This role interfaces and collaborates with internal stakeholders for global trade compliance activities, assuring process discipline, reliable delivery of Beams products while championing a compliance-focused culture. The individual will demonstrate awareness of import/export trade requirements for North America, Europe and Asia-Pacific regions and be the primary interface for Brokers, Customs, Government agencies, and external auditors.
Logistics - provide day to day operational leadership for R&D, non-GMP and GMP shipments and subject matter expertise on low and ultra-low cold chain shipping systems + lane validation aspects in support of CMC and Commercialization activities.
Responsibilities (included but not limited to):
- Develop and manage the Beam global import/export strategy and infrastructure to ensure all material used in R&D, clinical trials and future commercial activities are moved in accordance with the regulatory requirements of Customs, FDA, USDA, CDC and other applicable governmental agencies worldwide.
- Create, champion and lead Beam’s Trade Compliance committee ensuring Beam adheres to all applicable laws, regulations, and guidance regarding global import/export activity.
- Manage import and export transactions (including VATs, valuation, duties) by applying for permits & licenses and maintaining communication with Beam teams to ensure the trade compliance process meets project timelines and is compliant with all US and international customs regulations and laws.
- Primary respondent to all regulatory agency inquiries and issues. Investigates and develops strategy and response to ensure compliance in accordance with appropriate laws and regulations.
- Oversees compliance activities for CMO and 3PL vendors conducting import/export activities on behalf of Beam.
- Develop and maintain Quality Management System documents (manuals, policies, procedures, processes, and work instructions) to be consistent with current global regulatory requirements for Trade Compliance.
- Ensures that all Quality events, deviations, CAPAs are completed and closed on time.
- Develop KPIs for all aspects of logistics and trade compliance activities and provide reports to management.
- Stakeholder Management - builds and maintains relationships with counterparts in Legal, Finance, Accounting, Supply Chain, Procurement and other related business areas in the organization.
- Operational leadership for shipping team to manage all R&D, Non-GMP, GMP and future commercial shipments.
- Lead/support shipping systems and lane validation efforts for ambient, low and ultra low cold chains.
- Other related duties as assigned.
- Bachelors Degree, preferred in Business, Science or Law.
- 8-10 years’ experience in international trade with early and late-stage biotech/pharma companies. Formal training in Import/Export Compliance preferred. Customs Brokerage License desirable. Knowledge of Customs, FDA, USDA, EPA, DEA, FWS, CDC, State, Commerce, Census Requirements related to Import/Export.
- Strong understanding and experience with international trade compliance laws and regulations including economic sanctions, Harmonization Tariff system (HTS), country of origin, boycott laws and Free Trade Agreements.
- Expert knowledge of trusted trader programs including Customs-Trade Partnership Against Terrorism (C-TPAT) and Importer Self-Assessment (ISA).
- Expertise with managing Logistics within a network of both internal and external (CDMO) manufacturing sites.
- Ability to handle high complexity issues and problems with excellent decision-making skills and ability to navigate organization.
- Certified U.S Export Compliance Officer certification. Certified Customs Specialist.
- Import/Export auditing experience.
- HAZMAT Certification IATA and IMDG.
- Experience with both clinical and marketed products (US and European markets).
- MBA or Masters.
Knowledge and Skills:
- Possess excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
- Ability to author Standard Operating Procedures. Strong working experience with SharePoint, electronic Quality Management Systems, Visio, Word, Excel and PowerPoint.
- Ability to work independently and effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view.
- Ability to manage and influence at all levels of management, both internal and external, across multiple regions.
- Ability to manage internal and external resources (people, information, technologies, time and capital); allocates resources appropriately, given organization, group and individual goals and objectives to align with business imperatives.