Associate Director/Director, Logistics and Trade Compliance
Beam Therapeutics
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See open jobs at Beam Therapeutics.See open jobs similar to "Associate Director/Director, Logistics and Trade Compliance" Camford Capital.Position Overview:
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.
Qualifications (Required):
- 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.
Preferred:
- 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.
This job is no longer accepting applications
See open jobs at Beam Therapeutics.See open jobs similar to "Associate Director/Director, Logistics and Trade Compliance" Camford Capital.