Senior Manager, Global Logistics & Trade Operations

Responsibilities

• Performs all responsibilities in compliance with internal SOPs and external regulations.
• Bridges compliance issues to the attention of management.
• Ensures adherence to cGMP, GSP/GDP and SOX regulations.
• Implements solid transportation & storage relationships and distribution methods and protocols.
• Executes national and international distribution, of temperature-controlled products (API, DS, DP, BS and finished goods), ensuring safe compliant, on-time delivery and exemplary customer service.
• Identifies and implements solutions to improve the quality and efficiency of the supply chain.
• Facilitates and coordinates with warehouses, logistics carriers and couriers, and customs brokers regarding all aspects of transport service, including but not limited to order placement, building and reviewing shipping documents, tracking, receipt confirmation, and ensuring the physical and thermal quality of the product during transit.
• Serves as liaison with Supply Planning for distribution order management, transportation, delivery and resolution of challenges in support of the production schedule with CMOs and internal manufacturing sites.
• Identifies and communicates any shipment risks and supports recommendations and implementation of corrective actions to minimize supply risks.
• Establishes operational procedures for activities such as verification of incoming and outgoing shipments, temperature data logging, and on-time/at-temp delivery performance.
• Develops, implements and enforces SOPs for all aspects of logistics management, including import and export activities, transportation risk analysis and shipping validation for API, DS, DP, BS and Finished Goods.
• Manages and assess courier vendor’s performance and reports operational metrics (KPIs) to senior management, as well as any regulatory reporting requirements related to transportation and logistics activities.
• Led and measure processes to ensure logistics operations are completed with excellence.
• Processes the necessary ERP transactions according to standard operating procedures and SOX compliance guidelines and collaborates closely with Finance / Taxes teams.
• Collaborates with corporate and facility-based QA and QC counterparts to ensure audit readiness, and process control for all logistics activities.
• Participates in regulatory audits as needed.
• Supports and oversees daily and ongoing expenses to ensure that financial capital is used effectively.
• Aids in the annual budgeting of logistics expenses.
• Aids in compiling Lane Risk Assessments.
• Performs other duties as assigned, in a dynamic "start-up" environment.

Requirements

• Bachelor’s degree in Business Administration, Operations Management, Engineering or similar and 7+ years of progressive experience in Supply Chain within the biotech / pharmaceutical industry.
• Master’s degree and 5+ years of experience preferred.
• 3+ years in a logistics management role for Clinical and/or Commercial products, including experience in import/export processes, lot-level inventory management, chain of custody and traceability, budget management, warehousing technologies, and temperature-controlled distribution protocols, in a regulated pharmaceutical/biotech environment.
• Understanding of comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, 21 CFR Part 11, and Annex 13) and knowledgeable of relevant commercial laws and regulatory guidelines.
• Experience working in a global, complex supply chain organization within the biopharma industry.
• Strong understanding of import/export requirements and customs practices for US and EU.
• Direct experience with US customs audits is a plus.
• Strong ability to flex commercial processes.
• Experience in vendor oversight and managing external partnerships and relations.
• Experience with biologics (cold chain) and/or small molecule supply chain.
• Experience in vendor oversight and managing external partnerships and relations.
• Familiarity with risk management tools (FMEA, etc).