FTZ & Cell Therapy Trade Compliance Lead

AstraZeneca; California (MD); On-site; USD 89,000 - 134,000; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Health, dental, and vision coverage

Paid time off

Job summary

AstraZeneca Cell Therapy is seeking a Senior Specialist to lead FTZ operations across its cell therapy network, ensuring compliant movement of materials with strong traceability and audit readiness. You will partner with Manufacturing, Quality, Supply Chain, and external brokers to keep timelines and compliance aligned.

Experience in FTZ or bonded operations, 19 CFR Part 146 familiarity, and knowledge of HTS classifications and FDA/CBER import requirements are essential.

Qualifications

• Bachelor’s degree required in a related field and 5+ years in customs brokerage, import/export, or global logistics.
• Hands-on FTZ or bonded operations experience with strong documentation practices.
• Familiarity with HTS classification, FDA/CBER import requirements, and 19 CFR Part 146.
• Experience in regulated environments such as biopharma or temperature-controlled logistics.

Responsibilities

• Lead FTZ operations and compliance per 19 CFR Part 146 and site procedures.
• Manage FTZ admissions, transfers, removals, exports, and annual reconciliations.
• Ensure FTZ storage, traceability, and documentation accuracy for patient materials and raw materials.
• Coordinate import documentation, entry activities, and broker interaction to resolve issues.
• Oversee outbound FTZ shipments with accurate documentation and timing.
• Align FTZ activities with batch release and patient schedules with cross-functional teams.
• Monitor KPIs and drive root cause analysis for improvements in reliability and compliance.
• Develop and maintain SOPs, work instructions, and role-based training for FTZ processes.

Skills

FTZ operations

customs documentation

broker coordination

import/export execution

Part 146 familiarity

regulated environment experience

records and audits

Excel familiarity

inventory systems

Education

Bachelor’s degree in Supply Chain, International Business, Logistics, Life Sciences, or related field

Tools

Excel

Broker portals

Job description

AstraZeneca Cell Therapy is seeking a Senior Specialist to lead FTZ operations across its cell therapy network, ensuring compliant movement of materials with strong traceability and audit readiness. You will partner with Manufacturing, Quality, Supply Chain, and external brokers to keep timelines and compliance aligned.

Experience in FTZ or bonded operations, 19 CFR Part 146 familiarity, and knowledge of HTS classifications and FDA/CBER import requirements are essential.