Global Clinical Supply Compliance Operations Manager
This position within our company's Global Clinical Supply Compliance Operations is responsible for ensuring imports / exports are declared and shipped in compliance with local Customs and other government agency regulations and our company's Global Trade Compliance standards. This will include developing and implementing related processes and procedures to ensure compliance with applicable policies, regulations, and laws. Position will work with Global Trade Compliance, site shipping personnel, and Clinical and Research stakeholders across all global company locations. Position will also interact with Logistics, Transportation, Clinical Country Operations overseas, and outside vendors / shippers. Key challenges will include influencing all constituents and stakeholders to following trade policy and procedures and solving shipment specific issues when they arise.
Specifically, this role :
- Performs post entry reviews of import declaration and self-assessments on a selection of Import entries monthly, work with Customs Brokers to update entries for errors found in monthly audit.
- Determine if PSC (Post Summary Corrections) are needed and work with Customs Brokers to ensure PSC fillings are completed timely.
- Analyze ACE reports to ensure compliance adherence.
- Manage the TIB / IFE program for our Research and Development Division, ensuring all rules and regulations are adhere to for filing, work with stakeholders to receive documentation needed to close out TIB's.
- Maintain Audit, TIB, PSC Logs and maintain and report the post-entry self-assessment metrics.
- Support, as required, the C-TPAT yearly audit.
- Manages shipments received under FDA, USDA, EPA hold requirements for FTZ area.
- Monitoring the 2PR reviews, being the escalation for 2PR issues and inquiries.
- Outreach to our Research and Development Division stakeholders.
- Contribute developing strategic programs in GCS and rest of our Research and Development Division to ensure compliance with Import and Export regulations.
- Identify opportunities for trade compliance process improvements within GCS and rest of our Research and Development Division.
- Contribute to the maintenance and implementing trade compliance Standard Business Procedures, tools, systems, and training to ensure compliance and to ensure the appropriate processes are properly incorporated into GCS and rest of our Research and Development Division operations.
- Partners with area SMEs inside and outside of GCS on cross-functional initiatives, as appropriate.
- Provide US and global support to deploy our company's Compliance strategic goals and objectives aligned closely with business objectives.
- Work in our Global Trade Management systems including GTS in SAP and other systems to ensure trade attributes are stored and communicated to brokers and government agencies compliantly.
Qualifications :
High school diploma or equivalent required.Associate's / Bachelor's degree preferred.Two (2)+ years of experience in Trade Compliance required.Trade related certificate required.Customs Broker License a plus.Minimum of five (5) years logistics experience in the pharmaceutical industry of which a minimum of 2 years functional expertise with international trade.Knowledge of US Customs regulations and related experience.Knowledge of other partner government agency trade regulations.Prior experience interfacing with international 3rd Party vendors.Prior hands-on experience using Microsoft products (Outlook, PowerPoint, Excel and Word).Prior experience with global trade management systems like SAP GTS or other similar databases, very desirable.Proficient in English.Good project management skills.Demonstrated strong analytical and problem-solving skills.Sustained level of high performance while quickly processing high volumes of work.Awareness of diversity.