Senior Director, Logistics and Materials Management

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

The Senior Director, Logistics and Materials Management is accountable for the global Logistics, Distribution, Materials Management and Trade Compliance activities Ultragenyx.

This role is responsible for:

• Ensuring compliant and cost-effective delivery of GxP products through strategic and operational management of a network of 3rd party logistic providers (warehousing, distribution, transportation, and customs brokerage).
• Establishing and maintaining trade compliance policies and procedures in cooperation with corporate and external counsel and various government agencies. Responsible for import/export activities to ensure expeditious flow of international trade.
• Executing a robust global materials management program that includes management of supplier-sourced materials to third parties, holding of regional strategic inventory reserves for intermediate products, design, and management of the Ultragenyx cell bank inventory and responsibility for the product and location master data in the ERP system.

This position is located in Novato, California; Brisbane, California; or Bedford, Massachusetts. Flexibility to work from other locations will be considered for extremely qualified candidates only.

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

• Provide clear leadership and strategic direction to Logistics, Trade Compliance and Materials Management team.
• Oversee management of third-party logistics providers for the full biotechnology value chain from cell banking, drug substance and through to drug product. Align with regional supply chain partners on the management of regional finished product 3PLs. Responsibilities include, but are not limited to warehousing, distribution, transportation, and customs brokerage.
• Lead the management and continuous improvement of the distribution network to ensure consistency, efficiency, and high levels of service.
• Lead a team of logistics professionals ensuring the cost-effective, on-time and efficient and delivery of GxP materials between production facilities, warehouse locations, 3PLs and distributors.
• Develop and operationalize policies and procedures to maintain compliance to all applicable import/export regulations and standards. Oversee government partnership programs (e.g., C-TPAT)
• In support of our new gene therapy business, develop a real-time logistics reporting system and, partnering with our regional supply chain team, a “follow the sun” tracking capability for high value, ultra-cold shipment of pharmaceutical product.
• Validate all commercial transportation lanes and associate processes. Author and approve distribution protocols and work instructions for third party partners to ensure correct pack out, storage, pickup, and delivery of GxP product.
• Provide updates to senior management of new developments and potential risks/liabilities in the logistics network.
• Work closely with Finance to define valuation methodology per customs law requirements. Review and research duty mitigation strategies (e.g., protests, drawback, import for export) and make recommendations to management as applicable.
• Ensure business continuity plans are in place to avoid any supply disruptions and to ensure continuity of services to external and internal customers with an emphasis on developing a robust new process for the Ultragenyx cell banking inventory strategy.
• Support the rollout of a new master data management process and take ownership of the ERP system data and procedures as they relate to logistics.
• Develop annual budget plans and ensure logistics costs align with financial goals. Maintain insurance coverage for inventory in the network and ensure UGX is appropriately covered for all programs. Perform regular financial audits of services. Identify opportunities for supply chain related cost savings and implement solutions.
• Ensure compliance with GxP regulations, trade compliance and tax compliance in all areas of the regional supply chains.

Requirements:

• Language: Fluency in English. Working command of other languages is desirable.
• Education: A bachelor’s degree or local equivalent in a related field (Supply Chain, Business, Engineering). A master’s degree in business administration (MBA) is strongly preferred.
• Management experience: 10 or more years of experience in Logistics in the pharmaceutical or biotech industries. Three years of demonstrated people management experience. Strong preference for project management and pharmaceutical launch experience as well as a certificate in Lean / Six-sigma training (green belt or higher).
• Pharmaceutical experience: In-depth understanding of pharmaceutical industry procedures and regulations including GxP and other regulatory requirements – particularly as it pertains to transportation and logistics.
• Quality acumen: Familiarity with local and harmonized quality standards as they pertain to finished products and distribution. Experience operating in a pharmaceutical or biotechnology quality system and its related components (deviation, change control, etc…)
• Financial acumen and compliance: Subject matter expert level knowledge of international trade rules and trade compliance. Strong understanding of project finance and department budget / P&L.
• Information technology: Hands on experience with the implementation and / or operation of a scalable enterprise resource system (ERP) such as Oracle, SAP or similar system.
• Travel: Ability to travel domestically and internationally as required. #LI-CS1 #LI-Hybrid