Director, Cell Therapy Trade Compliance Operations

AstraZeneca US - Gaithersburg - MD Updated 11 October 2026
PharmaBiotech

Job description

Introduction to the Role At AstraZeneca Cell Therapy, we are building the capabilities required to deliver complex, personalized therapies through a highly coordinated, patient-centered, and globally scalable supply chain. As our network, geographic footprint, and operational complexity continue to expand, trade compliance operations are critical to ensure that patient materials, critical manufacturing inputs, intermediates, and finished product move compliantly, predictably, and without avoidable delay across borders. The Director, Cell Therapy Trade Compliance Operations will set the strategic direction and lead the global operating model for import/export and Free Trade Zone (FTZ) execution across the Cell Therapy network. This role will establish the capabilities, governance, processes, systems, and organization required to support reliable day-to-day execution, network expansion, and future commercial readiness. The Director will own operational performance and business continuity for cross-border trade execution, including shipment holds, customs delays, documentation issues, broker performance, FTZ operations, and other events that may affect patient timelines, manufacturing continuity, or inventory control. The role will drive standardization, digitization, visibility, and continuous improvement across the network while ensuring alignment with customs requirements, FDA/CBER import expectations, and applicable internal procedures. This role provides strategic and people leadership for the team responsible for operational trade compliance execution. The Director will partner closely with Patient Supply Operations, Global Supply Chain, Manufacturing, Quality, Regulatory, Finance, Procurement, Digital, and external service providers to ensure that trade compliance strengthens the delivery system supporting patient and product journeys. This is a hybrid position with a requirement to work in the office, on average, three days per week. Key Accountabilities Set the global trade compliance operations strategy and operating model for import/export and FTZ execution across the Cell Therapy network. Establish governance routines, execution rhythms, escalation pathways, role clarity, decision rights, and cross-site ways of working that support reliable and compliant operations. Own end-to-end operational performance for the import and export movement of patient materials, manufacturing inputs, intermediates, and finished product. Ensure compliant and timely execution of customs entry, shipment coordination, broker engagement, FTZ activity, documentation management, and issue resolution. Lead first-line escalation and business continuity management for cross-border trade execution issues, including shipment holds, customs delays, documentation deficiencies, broker performance concerns, FTZ operational issues, and other disruptions that may affect patient timelines, manufacturing continuity, or inventory control. Establish and maintain the trade compliance governance framework, including performance standards, escalation criteria, risk controls, operating reviews, compliance metrics, issue management, and decision-making forums across internal teams and external service providers. Drive process excellence and scalability through workflow simplification, bottleneck removal, standard work, automation, and repeatable operating methods that support network expansion, increasing shipment volumes, new modalities, and growing operational complexity. Define the digital and data strategy for trade compliance operations by partnering with business and Digital stakeholders to improve workflows, dashboards, KPI reporting, exception tracking, system integration, master data quality, and operational transparency. Own operational documentation and standard work for shipment execution, FTZ processes, broker coordination, escalation management, issue resolution, business continuity, and execution controls. Ensure that SOPs, work instructions, playbooks, training materials, and governance documentation remain current and aligned with regulatory and business requirements. Lead broker and service-provider strategy and performance management for customs brokers, freight forwarders, FTZ operators, and related partners. Establish performance expectations, monitor service delivery, lead issue resolution and escalations, and provide operational input to scorecards, sourcing decisions, and structured business reviews. Lead trade compliance readiness for network expansion involving new countries, sites, lanes, products, modalities, and operating models. Ensure that import and export requirements, broker readiness, documentation processes, customs classifications, permits, regulatory considerations, and FTZ implications are understood, resourced, and deployable before operational launch. Use data and risk-based insights to improve performance by monitoring trends across customs clearance, shipment holds, broker performance, FTZ execution, documentation quality, exception resolution, and compliance risk. Translate insights into corrective and preventive actions that improve predictability, compliance, resilience, and service reliability. Provide strategic partnership to senior stakeholders across Patient Supply Operations, Global Supply Chain, Manufacturing, Quality, Regulatory, Finance, Procurement, Digital, and Commercial Operations. Advise on trade compliance risks, investment requirements, operating-model decisions, and mitigation strategies. Build and lead a high-performing global team, establishing the organization, capabilities, role clarity, workload priorities, network coverage, and talent-development plans required to support current and future Cell Therapy operations. Provide coaching, development, performance management, and succession planning. Champion organizational learning and continuous improvement by embedding lessons learned, standardizing successful practices, strengthening controls, and ensuring that the trade compliance operating model evolves as programs progress from clinical development toward registration and commercialization. Support the clinical-to-commercial transition by establishing trade compliance capabilities, governance, service-provider models, and operational controls that can scale with commercial distribution, changing channels, country expansion, and future product and patient requirements. Essential Skills and Experience Bachelor’s degree in Supply Chain, International Business, Life Sciences, Logistics, Engineering, or a related field. 12+ years of progressive experi

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