Senior Specialist, Cell Therapy Trade Compliance

In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Cell Therapy Supply Chain team tasked with supporting critical development of supply chain logistics capability and process.

The Senior Specialist of cell therapy trade compliance owns day-to-day Free Trade Zone (FTZ) operations for AstraZeneca’s cell therapy manufacture sites to enable compliant, reliable import/export of patient materials and critical manufacturing materials for cell therapy. Ensure CBP/FDA compliance, inventory control integrity, and audit-ready records while aligning with vein‑to‑vein timelines and manufacturing schedules. 

Key Responsibilities 

• FTZ operations and compliance: Operate per 19 CFR Part 146 and AZ SOPs; manage admissions (CBPF 214), status elections (NPF/PF), zone-to-zone transfers, removals/exports, weekly entries, and annual reconciliation; support CBP/FDA/CBER reviews and close CAPAs. 

• Cell therapy material controls: Manage patient-specific inputs (apheresis, vectors, critical reagents) and cryogenic materials; ensure chain of identity/chain of custody, segregation, traceability, and cold/cryogenic storage integrity within the FTZ.

• Inventory, systems, and security: Maintain validated FTZ inventory records (ICRS/WMS) at lot/serial level; perform cycle counts and reconciliations; manage access controls/CCTV and documentation. 

• Import governance: Oversee HTS classification, valuation, origin, and PGA requirements; ensure FDA/CBER admissibility and correct entry data; review/approve broker entry packages (3461/7501) and run broker scorecards/KPIs. 

• Outbound from FTZ: Govern zone-to-export/domestic shipments for intermediates and finished product; ensure AES/EEI filings, license checks, temperature control, and documentation integrity. 

• Cross-functional alignment: Coordinate FTZ/import timelines with Manufacturing/Tech Ops, QA/QC, Supply Chain, and Logistics to meet GMP batch release and patient schedules. 

• Reporting and improvement: Track and report KPIs (admission cycle time, inventory accuracy, entry error rate, CBP/FDA holds, duty deferral/avoidance); lead root cause/Corrective Actions and drive process improvements. 

• SOPs and training: Maintain FTZ/import SOPs and role-based training; coach site teams on FTZ procedures and documentation standards. 

Qualifications 

• Bachelor’s in Supply Chain, International Business, Life Sciences, or related. 

• 5+ years in customs brokerage, import/export, or trade compliance with hands-on FTZ/bonded operations; biopharma/advanced therapies and temperature-controlled logistics preferred. 

• Working knowledge of 19 CFR Part 146, HTS classification, customs valuation, FDA/CBER import requirements

• Proficiency with FTZ inventory systems, broker portals and use of MS Excel

• Familiarity with GDP/GxP documentation and audit support

• Effective communication and stakeholder management 

Core Competencies: 

• Patient focus and integrity: Protects COI/COC, data integrity, and product quality in all FTZ activities supporting patient timelines.

• Deliver results: Executes admissions/entries/exports accurately and on time; sustains audit-ready records and high inventory accuracy. 

• Problem solving and judgment: Anticipates risks, resolves FTZ/import exceptions, and escalates appropriately. 

• Collaborate and influence: Aligns brokers, internal teams, and carriers without direct authority to meet compliance and schedule needs. 

• Data and digital: Ensures clean, timely system transactions; uses KPIs to drive corrective actions and continuous improvement