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Gilead Sciences

Senior Manager, Global Trade Compliance- Cell Therapy

Location
(CA)Hybrid
Posted
Posted today (employer shows the date only)
Source
Workday (employer's applicant tracking system)
Category
Corporate/Other
Industry
Pharma/Biotech
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From the employer's posting

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfill their aspirations. Join Kite and help create more tomorrows.

Job Description

The Senior Manager, Global Trade Compliance is responsible for leading and overseeing all import and export compliance activities supporting cell therapy operations across domestic and international markets. This role ensures adherence to U.S., Canadian, and global trade regulations by developing, implementing, and maintaining robust compliance programs, policies, procedures, and controls. The position serves as the subject matter expert for customs, FDA, USDA, CDC, and other government agency requirements, while partnering closely with internal stakeholders and external service providers to support the efficient movement of critical cell therapy products.

The role provides strategic oversight of customs brokerage activities, product classifications, export controls, recordkeeping, auditing, training, and compliance monitoring. The leader drives continuous improvement through the development of key performance indicators, identification of compliance gaps, implementation of trade compliance systems, and recommendations for cost-saving opportunities. Success in this position requires deep expertise in global trade compliance, strong cross-functional collaboration, and the ability to influence business decisions while ensuring regulatory compliance across the end-to-end supply chain.

Essential Duties and Job Functions:

  • Responsible for overseeing and leading the daily operations of all export and import compliance tasks and projects for cell therapy operations.
  • Manage Customs brokers to facilitate and support the efficient and timely customs clearance process.
  • Develop, implement, and maintain programs, policies, procedures, and controls to ensure compliance in accordance with new regulations, CBP (Custom and Border Patrol), CBSA (Canada Border Services Agency) guidelines, FDA, USDA, CDC and relevant agencies.
  • Interface with PGAs, internal and external customers on all matters pertaining to customs and import and export regulations.
  • Manage and assign HTS classifications, Export Control Classification (ECCN) FDA import product codes, USDA guidelines, Schedule B and country of origin information.
  • Manage import/export recordkeeping process in compliance with guidelines set forth by CBP, CBSA and Kite’s corporate policy and internal procedures.
  • Develop and implement detailed and targeted Trade Compliance training to cross-functional teams.
  • Ensure transactions are screened against Denied Person and Entities list for restricted end-uses, and diversion.
  • Implement audit program to include import entry filings, EEI export filings, and valuation methodology.
  • Conduct internal audit and assessment of business activities for adherence to import/export procedures throughout the business lifecycle, including early-stage review of new products and classification/characterization of commodities through final delivery to customer.
  • Develop, monitor, measure and report Key Performance Indicators (KPI) related to import/export activities with goal to drive ongoing process improvement.
  • Manage internal Trade Compliance and FDA information Databases.
  • Collaborate with IT on new Trade Compliance system and processes implementation.
  • Develop and foster relationships with internal departments, plant, and warehouse operations, including R & D, Logistics, Supply Chain, Commercial, Tax, Legal, involved in import/export activities.
  • Review opportunities for cost reductions and provide recommendations to Leadership Team.
  • All other duties as assigned.

Basic Qualifications:

  • Masters’ degree in Supply Chain, Engineering, Business, Life Sciences, or related field with 6+ years of relevant experience OR
  • Bachelor's degree in Supply Chain, Engineering, Business, Life Sciences, or related field with 8+ years of relevant experience OR
  • High School Degree with 12 + years of relevant experience

Preferred Qualifications:

  • Experience with Cell Therapy import, export and regulatory requirements in the US and international markets.
  • US Customs Broker License.
  • Strong technical knowledge of US/ Canada Customs laws and regulations.
  • Very strong FDA, USDA and CDC Import requirements experience.

…

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