North America Supply Chain_ Associate Director, Trade Compliance

Job Description
Responsible for the direction and oversight of the US based global trade activities of Sandoz Pharmaceuticals, both import and export. Ensures that all such activities are in compliance with departmental and corporate procedures as well as with all applicable federal, state, and foreign laws and regulations. Responsible for the establishment, implementation, and maintenance of the various Sandoz Trade Compliance Programs. Interacts and engages with all US government agencies (US Customs & Border Protection (CBP), Food and Drug Administration (FDA), Centers for Disease Control (CDC), US Department of Agriculture, BIS, Census, OFAC, APHIS, FWS, CITES, ITAR, DEA, etc) to ensure compliance and promote safety and security through the internal Supply Chain. Lead audit activities (internal and external). Proactive engagement with US legislators, US agencies, and pharmaceutical interest groups to promote expedited border crossing for highly compliant companies.

RESPONSIBILITIES
• Establish, monitor, maintain, and communicate new or revised US Trade regulatory requirements and any US Customs, FDA, and Other Government Agency (OGA) trade compliance and /or security programs/initiative (i.e. C-TPAT, ISA, SSC, etc.) in which Sandoz may participate.
• Builds effective relationships with US agencies (FDA, CBP, USDA, etc.) that oversee border crossing activities as well as with external and internal stake holders. Play an active role in pharmaceutical interest groups that engage in import and export activities and compliance programs.
• Act as a single point of contact toward the “CBP Center of Excellence and Expertise” in all trade, security, and compliance related aspects.
• Establish sound business relationships and an escalation process within FDA to address and solve any compliance issues that may lead to a drug shortage or any disruption in the current supply chain.
• Challenge, revise, and give regulatory input on FDA “Bills”, “Guidelines”, and “Code of Federal Regulations (CFR)”.
• Inform, communicate, train, and guide Sandoz import community on FDA rules and regulations on commercial, clinical trial, and research material.
• Inform, communicate, train, and guide Sandoz import community on CBP, USDA, and OGA relevant compliance and regulatory aspects.
• Establish, implement, maintain, and audit the Sandoz Trade Compliance Program via policies, standard operating procedures, internal assessments, and trade metrics to ensure trade regulatory compliance for Sandoz operations, while at the same time minimizing duty / outlays and liability.
• Manage and administer the Trade Compliance Program (TCP) for Sandoz. Benchmark and challenge current capability.
• Maintain, review, and distribute all trade content and regulatory updates (Federal Register, Government Web Sites, conferences, etc) to involved personnel to maintain compliance levels. Act as the resource for foreign trade laws, practices and requirements as they affect import /export activities.
• Ensure authorized brokers and forwarders are in compliance with defined Trade Metrics and procedures.
• Maintain the health of the TCP through internal assessment and complete Compliance Improvement Plans (CIPs) as needed. Conduct the Sandoz trade compliance training program for employees, its vendors, and any designated affiliates whereby Sandoz is the Importer or Export of Record.
• Mange the Trade Compliance Recordkeeping Program (administrative and transaction records).
• Classify and request any required binding rulings or classification requests, import or export permits/licenses for all products, technologies and deemed export of NPC. Maintain the classification matrix for Sandoz.
• Manage all post-entry, refund, and fine and penalty situations as they arise and coordinate with Legal as needed. Submit any prior disclosures or voluntary tenders, with Legal and management approvals.
• Develops & administers integrated logistics strategies in support of Global SCM objectives and ensure that customer service and other SCM KPIs are achieved within existing resource constraints.
• Challenge and give feedback on laws, guidelines, and processes that impact Supply Chain processes.
• Establishes performance management measurements and effective departmental employee development plans.

KEY PERFORMANCE INDICATORS
• Ability to comply and implement processes/procedures in a timely manner for new or revised trade laws or programs as required by law.
• Issuance of the Trade Compliance Program Manual and Corporate Policy Statement with annual update and any regulatory updates needed during the year.
• Distribution and education of the Sandoz Trade compliance Program to include a minimum of 4 multiple associated training sessions per year.
• Conduct annually at least one risk-based internal assessment for import and export.
• Minimize and/or mitigate any fines, penalties, or liquidated damages with FDA, CBP, and OGA.

JOB DIMENSIONS:
• Must maintain trade regulations, records, education for over 25 governmental agencies.
• Has Power of Attorney for timely communication and response to government agencies.
• Works in a team environment with all Sandoz departments, customers and vendors to ensure maximum trade compliance is achieved with minimal disruption to Sandoz business practices.
• Has broad authorization to hold any import or export shipment that is perceived to be non-compliant. Then to conduct a thorough review and obtain any required government, legal, or managerial approvals before proceeding or cancelling the transaction.
• Supervisor all trade compliance for Sandoz at multiple sites and interacts with approximately 15 internal departments (legal, finance, tax, controller, inventory, shipping, purchasing, R&D, contracts, receiving, etc).
• Supervisor trade compliance for outside vendors which includes: brokers, forwarders, and other Sandoz third party warehouse and/or service providers.
• Knowledgeable in all trade compliance regulations for various categories of goods. Examples include: pharmaceuticals, cosmetics, nutritional supplements, plant equipment, chemicals, packaging, trade show material, printed materials, etc.
• Manages US Sandoz Global Trade activities of over $600 Million of goods per year
• Manages approximately 2500 import/export shipments per year (95% import)
• Minimizing processing time for import/export shipments is critical
• This position will require travel up to 30%