Business Process Specialist - Logistics Process & Compliance, CVRM

The Position Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. The facility's core is defined by Innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028. Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and shape the culture of our organization for the next generation. Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine. The Opportunity You will serve as a pioneering force during our pre-startup build-out and post-launch operations. You are responsible for ensuring that our end-to-end intralogistics processes, material flows, and automated warehousing infrastructure comply strictly with cGMP regulations, Health Authority expectations, and Roche Global Quality Standards. Working in a paperless, highly automated environment, you will bridge the gap between logistics engineering, warehouse operations, quality assurance, and digital technology systems. What You'll Do Operational Readiness & System Build-Out: Act as the business process expert for SAP S/4HANA (EWM), Automated Storage and Retrieval Systems (ASRS), Automated Guided Vehicles (AGVs), Autonomous Mobile Robots (AMRs), and Warehouse Control Systems (WCS). Material Flow & Process Optimization: Partner with cross-functional engineering, robotics, and operations teams to define site-level intralogistics processes, material routing, and a Plan for Every Part (PFEP) and Plan for Every Flow (PFEF) for direct raw materials, components, consumables, and cold-chain Work-In-Progress (WIP). Quality & Compliance Architecture: Author and review logistics Standard Operating Procedures (SOPs), validation protocols, and commissioning documentation for automated logistics systems and temperature-controlled storage (+2 to +8°C, -20°C, and ambient). Equipment Qualification Support: Collaborate with automation vendors and Engineering to support set-up, testing, and commissioning activities for material handling equipment, downflow booths, and automated pallet conversion systems. Compliance & Quality Assurance: Serve as the Primary Subject Matter Expert (SME) during internal and regulatory audits (FDA/EMA) for warehousing, material handling, cold-chain integrity, and distribution processes. Deviation Management & Continuous Improvement: Support and / or own quality events, lead root-cause investigations into logistics deviations or temperature excursions, and implement CAPAs utilizing Lean Six Sigma principles. Operational Performance Monitoring: Monitor daily intralogistics KPIs, optimize dock-to-stock and kitting cycle times, and resolve throughput bottlenecks in material flow between the warehouse and production suites. Data Integrity & Change Control: Manage logistics change controls, maintain SAP EWM master data, and ensure data integrity across all automated logistics platforms. Develop Data Visualization Strategy: Partner with IT/OT and the OpEx teams to develop a strategy for data visualization for real time management of logistics operations.. Key Skills, Abilities, and Competencies Technical M…

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