Associate Director, Cell Therapy Trade Compliance Operations
AstraZeneca US - Gaithersburg - MD Posted 13 July 2026
PharmaBiotechRegulatory AffairsQuality Assurancegdpemafdacro
Job description
Associate Director, Cell Therapy Trade Compliance Operations Introduction to 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 increasingly critical to ensuring that patient materials, critical manufacturing inputs, intermediates, and finished product can move compliantly, predictably, and without avoidable delay across borders. The Associate Director, Cell Therapy Trade Compliance Operations leads the operating model for import/export and Free Trade Zone (FTZ) execution across the cell therapy network. This role is responsible for building scalable, reliable, and compliant operational processes; leading first-line escalation and business continuity for cross-border execution; and strengthening broker performance, visibility, digitization, and standardization to support future growth and commercial readiness. This role also provides people leadership for team members responsible for operational trade compliance execution and partners closely within Patient Supply Operations, Global Supply Chain, Quality, Regulatory, and Digital teams to ensure cross-border trade requirements strengthen the delivery system that supports patient and product journeys. This role is a hybrid position with a requirement to work in the office three days a week. Accountabilities: Lead the trade compliance operating model for import/export and FTZ execution across the cell therapy network, including global execution rhythms, governance routines, escalation pathways, role clarity, and cross-site ways of working that support reliable daily operations. Lead import/export and FTZ execution for patient materials, manufacturing inputs, intermediates, and finished product, ensuring compliant and timely execution of customs entry, shipment coordination, broker engagement, FTZ activity, and issue resolution in line with customs requirements, FDA/CBER import expectations, and internal procedures. Own first-line escalation and continuity management for cross-border trade execution issues, including shipment holds, documentation issues, customs delays, broker performance concerns, and FTZ operational issues that may impact patient timelines, manufacturing continuity, or inventory control. Drive process excellence and scalability across trade compliance operations through workflow simplification, bottleneck removal, standard work, and repeatable operating methods that support network expansion, increasing shipment volumes, and growing operational complexity. Strengthen digital enablement and operational visibility by partnering with business and digital stakeholders to improve workflows, dashboards, KPI reporting, exception tracking, and data quality, reducing manual effort and enabling more scalable and data-driven trade compliance operations. Own operational documentation and standard work for shipment execution, FTZ processes, broker coordination, escalation management, issue resolution, business continuity, and execution controls, ensuring SOPs, work instructions, playbooks, and training materials remain current, practical, and aligned to regulatory and business requirements. Lead performance management and broker management for customs brokers, freight forwarders, and related service providers, including performance monitoring, service issue management, escalation handling, and operational input to scorecards and structured performance reviews. Support network readiness and expansion for new countries, sites, lanes, products, and operating models by ensuring trade compliance execution requirements , broker readiness, documentation processes, and FTZ implications are understood and deployable. Use data to improve operational performance by tracking trends and risks across customs clearance, shipment holds, broker performance, FTZ execution, and exception resolution, and by driving corrective actions that improve predictability, compliance, and service reliability. Provide strong people leadership , building and leading a high-performing team through clear direction, role clarity, workload prioritization, coaching, development, and performance management to ensure strong execution quality, accountability, collaboration, and effective network coverage. Essential Skills/Experience: Minimum education: a Bachelor’s degree in Supply Chain, International Business, Life Sciences, Logistics, Engineering, or a related field. 8+ years of experience in customs brokerage, import/export operations, trade compliance, global logistics, or supply chain operations in a regulated environment Strong experience with FTZ or bonded operations, customs entry processes, broker governance, and import/export execution Demonstrated experience leading operating models, process improvement, digitization, and scalable business processes Clear communication, stakeholder management, sound judgment, and the ability to lead within a matrixed organization are essential. Desirable Skills/Experience: Advanced degree such as MS, MBA, or equivalent. Experience supporting clinical-to-commercial transition, global expansion, country enablement, or network scale-up in a complex supply environment. Experience with Excel, Power BI, Tableau, Smartsheet, or similar tools for reporting, workflow management, and operational visibility. Experience supporting time-critical, cryogenic, temperature-controlled, or highly specialized logistics operations. Working knowledge of GDP, GxP, and regulated logistics practices relevant to cross-border execution in biopharma environments. The annual base pay (or hourly rate of compensation) for this position ranges from 115,919.2 to 173878.8 USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. When we put unexpected teams in the same room, we unleash bold thinking with the po
Stand out for this role
NoxPharm tailors your CV to this exact job description — matching the keywords recruiters and ATS systems screen for. Built for pharma & life sciences.
Tailor my CV now — free to trySimilar Pharma jobs
Technician I - Facilities, Maintenance
Catalent — Madison, WI
Technician I - Facilities, Maintenance
Catalent — Madison, WI
Supervisor, Facilities & Engineering
Catalent — Harmans, MD
Laboratory Team Leader
Catalent — Greenville, NC
Technical Writer
Catalent — Greenville, NC
Enterprise Data Integrations Specialist
Catalent — 2 Locations