Senior Manager, Global Logistics & Trade Operations

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description:  The Senior Manager of Global Logistics & Trade Operations is responsible for the planning, coordination and execution of distribution for BeOne’s Finished Products (FP), Active Product Ingredients (API), Drug Products (DP), Samples and any other products. This includes managing budgets, organizing schedules & routes, depot supplier management, facilitating imports/exports, and ensuring legal/regulatory compliance is always adhered to. The role will interface cross-functionally with Supply Planning, Manufacturing, Procurement, QA and a network of CMOs to provide logistic support in execution of production plans. In this role, you will use your experience with cGMP and GSP/GDP environments and help BeOne build a robust logistics infrastructure, optimizing the overall supply chain to help achieve the ultimate goal of delivering BeOne’s pipeline to patients. Responsibilities: Performs all responsibilities in compliance with internal SOPs and external regulations. Brings 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. Manages import and export process including ensuring compliance with local and regional import/export regulations particularly for US, EU and other regions. 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. Lead and measure processes to ensure logistics operations are completed with excellence. Process the necessary ERP transactions according to standard operating procedures and SOX compliance guidelines and collaborate 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. Participate in regulatory audits as needed. Coordinates with quality team on deviations/CAPA for incidents that occur during transportation. Support and oversee daily and ongoing expenses to ensure that financial capital is used effectively. Assists with the annual budgeting of logistics expenses. Assists in compiling Lane Risk Assessments. Perform other duties as assigned, in a dynamic "start-up" environment. Education and Experience Required: 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 Understands 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 Strong understanding of import/export requirements and customs practices Experience with lane risk assessments, and shipping lane/process qualification including IQ,OQ, PQ is a plus. Experience in change management, deviation investigation and CAPA implementation. Ability to foster a culture of continuous improvement and operational excellence and perform as an influential leader without positional authority Strong ability to collaborate and build strategic relationships with internal (Commercial, Quality, CMC, Finance etc) as well as external (3PLs, CMOs, Couriers, etc.) stakeholders Ability to wo