Description
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. 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 include operating per 19 CFR Part 146 and AZ SOPs, managing admissions, status elections, zone-to-zone transfers, removals/exports, weekly entries, and annual reconciliation, as well as supporting CBP/FDA/CBER reviews and close CAPAs. Additionally, the role involves managing patient-specific inputs, ensuring chain of identity/chain of custody, segregation, traceability, and cold/cryogenic storage integrity within the FTZ. Maintain validated FTZ inventory records at lot/serial level, perform cycle counts and reconciliations, manage access controls/CCTV and documentation. Oversee HTS classification, valuation, origin, and PGA requirements, ensure FDA/CBER admissibility and correct entry data, review/approve broker entry packages and run broker scorecards/KPIs. Govern zone-to-export/domestic shipments for intermediates and finished product, ensure AES/EEI filings, license checks, temperature control, and documentation integrity. Coordinate FTZ/import timelines with Manufacturing/Tech Ops, QA/QC, Supply Chain, and Logistics to meet GMP batch release and patient schedules. Track and report KPIs, lead root cause/Corrective Actions and drive process improvements. Maintain FTZ/import SOPs and role-based training, coach site teams on FTZ procedures and documentation standards. Qualifications include a 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, and proficiency with FTZ inventory systems, broker portals, and MS Excel. Core competencies include patient focus and integrity, deliver results, problem-solving and judgment, collaborate and influence, and data and digital.