Director, Cell Therapy Trade Compliance Operations
$145k - $213kJobleads-US
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 experience in customs brokerage, import/export operations, trade compliance, global logistics, or supply chain operations within a regulated environment.
- Demonstrated experience owning or leading global trade compliance operating models across multiple sites, countries, products, lanes, or business units.
- Strong experience with Free Trade Zone or bonded operations, customs entry processes, broker governance, import/export execution, documentation controls, and cross-border issue resolution.
- Proven ability to establish and scale governance frameworks, performance-management processes, risk controls, standard work, and business-continuity capabilities.
- Demonstrated success leading process transformation, operational digitization, data visibility, workflow improvement, and scalable business-process design.
- Experience managing customs brokers, freight forwarders, FTZ operators, and other external service providers, including performance reviews, service-level expectations, escalation management, and corrective actions.
- Strong knowledge of customs and import/export requirements relevant to biopharmaceutical operations, including FDA/CBER import expectations and applicable country-specific requirements.
- Working knowledge of GDP, GxP, and regulated logistics practices relevant to cross-border execution in biopharmaceutical environments.
- Demonstrated people-leadership experience, including building, developing, and leading high-performing teams in a matrixed and globally distributed organization.
- Executive-level communication, stakeholder-management, influencing, and decision-making skills, with the ability to translate complex trade compliance matters into clear business risks, recommendations, and actions.
- Ability to balance strategic leadership with operational rigor and intervene directly when necessary to protect patient supply, manufacturing continuity, compliance, or inventory control.
- Flexibility to support global time zones and time-critical operational escalations as needed.
Desirable Skills and Experience
- Advanced degree, such as an MS, MBA, or equivalent.
- Experience supporting clinical-to-commercial transition, global expansion, country enablement, or network scale-up in a complex biopharmaceutical supply environment.
- Experience with cell therapy, gene therapy, ATMPs, biologics, vaccines, or other specialized pharmaceutical products.
- Experience supporting time-critical, cryogenic, temperature-controlled, or highly specialized logistics operations.
- Experience using Excel, Power BI, Tableau, Smartsheet, SAP, or similar tools for reporting, workflow management, data analysis, and operational visibility.
- Experience establishing or improving trade compliance technology, broker‑management systems, shipment visibility tools, or exception‑management platforms.
- Experience presenting trade compliance strategies, operational risks, investment proposals, and performance outcomes to senior leadership or governance bodies.
The annual base pay (or hourly rate of compensation) for this position ranges from144,997.6 to 212,996.4 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 coveragein accordance withthe terms of the applicable plans.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life‑changing medicines. In‑person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca
Here, you are trusted to take accountability and make change real—pairing scientific ambition with digital innovation to speed therapies to patients. You will work with expert partners across disciplines, using data, automation, and practical problem‑solving to reimagine how critical materials flow through a complex, regulated network. We move decisively and learn fast, valuing kindness alongside ambition, so you can contribute boldly, grow your craft, and see the impact of your decisions reflected in patient outcomes and enterprise progress.
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
#J-18808-Ljbffr Jobleads-US- ...AstraZeneca plc is seeking a Director of Cell Therapy Trade Compliance Operations to define and lead the global operating model for import/export and FTZ execution across the Cell Therapy network. You will own performance, continuity, and compliance, partnering with...Operations
$142k - $213k
...to role: At AstraZeneca Cell Therapy, we are building the capabilities... ..., and digitally enabled operating model. As we evolve from... ...therapy ambition. The Director leads the Vein-to-Vein Operations... ..., Manufacturing, Quality, Trade Compliance, Digital, Delivery...OperationsHourly payTemporary workWork at officeShift work3 days per week$115.92k
...Associate Director leading trade compliance operations for AstraZeneca's cell therapy supply chain network. Responsible for building scalable import/export and Free Trade Zone processes, managing cross-border execution, leading operational teams, and strengthening vendor...Operations$218.33k - $327.49k
...all our people. Within the AstraZeneca Cell Therapy Enterprise, our ambition is to realize... ..., and competitor analytics. The Senior Director, Global Analytics & Insights, Cell Therapy... ..., Regulatory, Market Access, and Operations teams, bringing objective insights to key...OperationsHourly payFull timeTemporary work- ...AstraZeneca seeks a Director to lead Vein-to-Vein Operations for cell therapy, overseeing the transition from reactive logistics to proactive end-to-end patient... ..., and scalable operating models while ensuring compliance and patient-centered service delivery across global...Operations
$159.18k - $238.77k
.... Within the AstraZeneca Enterprise Cell Therapy Unit, our ambition is to realize the full... ...’s Therapeutic Area Units. The Director, Portfolio and Capacity Management role... ...a member of the Business Planning and Operations team within Enterprise Cell Therapy, and...OperationsTemporary workWork at office- Associate Director, Research Strategy and Operations, Hematology R&DAstraZeneca is a global, science-led, patient... ..., Antibody-drug Conjugates, Cell Therapy and Epigenetics) to help address... ...translational research portfolio.Coordinates compliance for samples and associated data...OperationsHourly payFull timeTemporary work
- ...Rockville Manufacturing Center (RMC), a GMP cell therapy manufacturing facility. Provide day-to-... ...longer-term leadership for facility operations, maintenance, reliability, calibration... ...practices. • Ensure the reliability, compliance, availability, and efficient operation...OperationsHourly payTemporary workFor contractors
$118.75k - $178.13k
...Lead facilities and maintenance operations for a GMP cell therapy manufacturing center in Rockville. Oversee a technical team, ensure regulatory compliance and equipment reliability, and drive continuous improvement to support efficient production and site growth. Responsibilities...Operations- ...clinical-stage biotechnology company developing innovative cell-based therapies. This executive will establish and maintain a phase-appropriate... .... The VP will collaborate with Clinical, CMC/Technical Operations, Manufacturing, R&D, and external #J-18808-Ljbffr Planet PharmaOperations
$210.86k - $242.79k
...Director, Patient Services Strategy, US Cell & Gene Therapy Office Location: Gaithersburg, MD (3 days minimum per week)... ...Marketing, Market Access, Commercial Operations, Medical, Digital, and launch... ...investments, negotiating trade-offs, and scaling asset-specific...OperationsHourly payTemporary workWork at officeRemote work3 days per week- AstraZeneca seeks a Senior Director of Manufacturing Science and Technology (MSAT) to lead cell therapy manufacturing across a global... ...partnering with Manufacturing Operations, Quality, Supply Chain and... ...strategy, and ensure regulatory compliance with cGMP and ICH guidelines...Operations
- ...AstraZeneca in Gaithersburg is seeking a Director of Portfolio and Capacity Management to lead strategic resource planning within the Enterprise Cell Therapy unit. You will manage capacity, forecast demand, and collaborate with senior leaders to optimize resource allocation...Work at office
$218.33k - $327.49k
...AstraZeneca seeks a Senior Director to lead analytics and insights for its cell therapy enterprise, driving strategic decisions across clinical development and commercialization. This role requires building market and competitive understanding for emerging cell therapies...Shift work$267.91k - $401.87k
...AstraZeneca seeks an executive director to shape strategy and drive commercial initiatives for cell therapy across defined disease areas. This role leads end-to-end portfolio... ...and understanding of pharmaceutical R&D operations Compensation: $267,914-$401,870 annual...Operations- DescriptionTechnical SummaryThe Director of Treasury oversees the organization's treasury... ...cash positions, liquidity, banking operations, payment systems, merchant processing,... ...ensure operational resilience, regulatory compliance, and strong risk management.The Director...OperationsWork experience placementBank staff
- ...Jackson Therapy Partners is seeking an experienced Rehab Director for a full-time role with an area client where you'll... ...clinical care and customer service, compliance with state and federal... ...Responsibilities include day-to-day clinic operations, employee supervision,...OperationsFull timeTemporary workRelocation packageMonday to Friday
- Lead warehousing and distribution operations for the Rockville Manufacturing Center (RMC), ensuring reliable material flow for cell therapy manufacturing and protecting product quality... ..., cost and delivery performance in compliance with Good Distribution Practice (GDP),...OperationsHourly payTemporary workLocal areaShift work
$160k - $218k
...REGENXBIO has pioneered what’s possible in gene therapy. Today, we are advancing a pipeline of... .... The opportunity As Associate Director, Regulatory Affairs, you'll lead global regulatory... ...Represent REGENXBIO with industry teams, trade associations, and professional...Work experience placementSummer workLocal area$270.19k - $405.28k
...AstraZeneca seeks an Executive Director to lead global clinical operations and program management for cell therapy development across multiple franchises. The role involves... ...five countries while ensuring regulatory compliance and operational excellence. Responsibilities...Operations$110k - $130k
...driven A/E industry, while also owning the employee relations, compliance, and performance functions that will allow our growing... ...initiatives Perform other HR duties as assigned in support of firm operations Education and Experience Requirements: Minimum...OperationsFull timeContract workWork at officeLocal areaFlexible hours$267.91k - $401.87k
...AstraZeneca seeks a Strategy and Commercial Executive Director to lead end-to-end cell therapy strategy for defined indications, driving commercial initiatives... ...Understanding of pharmaceutical business operations including R&D and product lifecycles Experience translating...Operations$210.86k - $242.79k
...AstraZeneca seeks a Director to develop and execute the US patient services strategy for its cell and gene therapy portfolio. This role involves designing support models across... ...Responsibilities Own US patient support strategy and operating model, defining priorities, capabilities,...Operations$192.38k - $218.25k
...manner otherwise, please contact us at .Job DescriptionThe Director, Employee Relations & Compliance is responsible for building and leading the systems,... ...framework that translates requirements into clear operating processes, controls, ownership, and accountability.Job...OperationsFull timeWork at officeLocal area$125k - $135k
...Description Overall Position Purpose The Director of HR Operations position exists to provide strategic leadership and operational... ...plans and execution across compensation, benefits, compliance, HR systems, employee relations, and facilities operations...OperationsFull timeContract workWork at officeRemote workWeekend workAfternoon shift$142k - $213k
...As the Director – Clinical Demand Planning & Optimisation... ...cost, risk, and waste trade-offs ~ Ensures... ...through others. Clinical Operations (e.g., GSAD, clinical... ...operations to deliver therapies that change lives. You... ...nerve center of cell therapy logistics and...OperationsHourly payTemporary work$162.54k - $243.8k
...Great Place to Work. About the RoleThe Director of Cyber Threat Intelligence will lead a... ...function within AstraZeneca’s Cybersecurity Operations division, managing a team of analysts to... ...making data-driven decisions with clear trade-offs and confidence levels. Technical...OperationsFull timeTemporary workWork at officeFlexible hours3 days per week- A market research firm is seeking an HR & Administration Manager to oversee HR leadership, administrative operations, IT management, and corporate compliance. The ideal candidate will have a Bachelor’s degree and at least 7 years of experience in HR or administrative management...OperationsCasual work
- X Energy, LLC is seeking a Director of Employee Relations & Compliance to design and lead scalable ER and compliance programs for a growing, multi-location... ...business leaders to manage complex employee matters and drive compliant operations. #J-18808-Ljbffr X Energy, LLCOperations
- AstraZeneca is seeking a Senior Specialist, Cell Therapy Vein-to-Vein Coordinator to manage end-to-end patient and product journeys. You... ...deliver autologous cell therapy, coordinating with Clinical Operations, Manufacturing, Quality, and couriers to ensure on-time, compliant...Operations
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Cell Therapy Trade Compliance Operations. Be the first to apply!
- director global regulatory affairs Gaithersburg, MD
- head compliance Gaithersburg, MD
- senior regulatory manager Gaithersburg, MD
- regulatory manager Gaithersburg, MD
- manager regulatory affairs Gaithersburg, MD
- compliance manager Gaithersburg, MD
- regulatory affairs manager pharmaceutical Gaithersburg, MD
- regulatory affairs director Gaithersburg, MD
- senior director regulatory affairs Gaithersburg, MD
- compliance director Gaithersburg, MD



