Warehouse & Distribution Validation Manager – Baxter Healthcare – Belgium
This position is part of Supply Chain, Global Logistics and is responsible for managing all warehouse and distribution validation activities for the global distribution of Baxalta products. This position coordinate and manage validation activities related to the development and implementation of new warehousing and distribution processes with 3PL’s globally.
More specifically, this position is responsible for:
– Overseeing global validation and qualification of warehouse and distribution activities through a network of 3PL’s.
– Implementing a center-led approach in the design, harmonization and validation of logistics solutions for warehousing and distribution of BioScience products according to global GDP, local regulatory, and customer requirements.
– Implementing compliant distribution solutions and controlling end-to-end logistics processes for the distribution of BioScience products to Commercial Market in a complex and high-regulated environment (cGMP, cold-chain, regulations…).
– Actively supporting strategic initiatives and validation activities as assigned in the area of logistics warehouse and distribution of Baxalta products and materials at CMO’s/Manufacturing sites/DC and 3PL’s
The position is expected to have a solid understanding of industry standards in logistics, warehousing and distribution as well as validation compliance requirements and is also required to provide technical knowledge and strategic perspective for the development, refinement and implementation of global distribution network for Baxalta products.
This position is the key liaison within all Baxalta functional areas in deploying warehouse and distribution validation activities for Baxalta products globally. The position reports to the Director of Global Transportation and Distribution Strategy.
Essential Duties and Responsibilities:
The following responsibilities are among the main duties performed by the Manager, W&D Strategy and Validation:
– The incumbent lead the development and deployment of a standard warehouse operations and systems in compliance with Baxalta Cold Chain Storage and Distribution and Regulatory requirements. This includes compliance to GDP.
– Manage compliance of warehousing and distribution activities with other departments (Global Quality, Supplier Quality, Global Logistics, Regional Operations team) to meet established validation policies and procedures, cGMP requirements, and industry standards.
– Independently analyzes and interprets validation data provided by 3PL’s,evaluate needs for additional validation supports (consultants), makes independent tactical decisions based on data, develops project strategies align with global network strategy and global compliance requirements and drive continuous improvement for storage and distribution of BioScience products according to regulatory, logistics, and customer requirements.
– Evaluate the need for outsourcing activities related to preparation and execution of validation protocols, data analysis and final reporting and control execution plans.
– Manages annual revalidation schedules for assigned sites and regions
– Contributes and works on Validation activities for other sites other than the assigned sites as needed
– Provide warehouse and distribution validation input during regulatory
– Harmonizing logistics supplies (such as temperature data loggers, insulated packaging) by optimizing quality, cost and operation requirements.
– The assessment of quality and regulatory requirements, design and validate shipping processes together with Global Logistics Validation and Program Management, Global Packaging Engineering, Global Quality and Global Logistics Operations and Regional Commercial Logistics & Distribution team.
– Supporting the implementation of compliant logistics processes (transportation, warehousing, distribution and supplies) for the end-to-end distribution of Finished Goods from BioScience 3PL DC to Customers.
– Ensuring successful launches of Bioscience products.
– Excellent interpersonal and management skills are essential. Ability to operate independently and interact with other functions (global logistics validation, global packaging engineering, global quality, Commercial logistics, Warehouse
– In-depth knowledge of distribution centers, warehouse design and layout, cold chain storage and distribution requirements, qualification and validation policies and procedures, cGMP requirements, and industry standards
– Complete, in-depth understanding of all aspects of the pharmaceutical business, Cold Chain Logistics Transportation and Packaging, Good Distribution Practice
– Demonstrated understanding of GxPs, Good Manufacturing Practices (cGMP), 21 CFR Part 11, WMS, software and equipments, and standard validation practices
– Strong leadership trait to lead the group and organization for high compliance result
– Excellent communication skills (with staff, colleagues, suppliers, and senior
management) both written, oral, and presentations
– Strong demonstration of use of critical thinking and problem solving skills to address, correct, and prevent issues or make best decisions
– Ability to produce results with minimal supervision and simplify the complex into operational processes with sustainable results
– Supervises, coaches, and develops others. Drives results through team leadership and self. Experience to manage internal teams at remote locations.
– High to expert level of MS office tools (Word, ppt, excel, access, project)
– Able to work in fast-moving environment. Domestic (and/or International) Travel up to 25%
Education and/or Experience:
– Bachelor’s Degree is required. MBA and APICS Certification preferred.
– 7+ years’ experience in logistics, Warehousing and Distribution is required, with a minimum of 2–4 years relevant work experience within a global organization; Proven working experience to handle biopharmaceutical import and export activities, including working with different global government agencies and authorities
– Experience working in Biopharmaceutical or highly regulated and compliance industry, high-value cold-chain/temperature-controlled products.