Global Supply Chain Process Architect – Warehousing & Regulatory Compliance

By applying Systems Thinking and Lean methodologies, this role bridges physical warehouse layouts, digital execution systems (WMS/RF/Automation), and strict regulatory standards (e.g., GDP, cGMP, ISO 13485) to ensure secure, compliant, and cost-effective product storage and fulfillment worldwide.

Core Responsibilities

1. Strategic Warehouse Process Architecture & Systems

• E2E Warehouse Process Ownership: Lead the architectural design, standardization, and L1–L3 process mapping for warehouse operations, including Inbound Receiving, Putaway, Kitting, Pick/Pack, Shipping, Cycle Counting, and Returns Management.
• WMS & Automation Design: Partner with IT and BPM to translate physical warehouse workflows into enterprise software requirements (e.g., WMS), ensuring robust data integrity and system interfaces.
• Design for Distribution: Establish global layout standards, material flow designs, and slotting strategies across global distribution centers, regional hubs, and manufacturing warehouses.

2. Regulatory Compliance & Quality Governance

• Global GDP & cGMP Compliance: Act as the primary technical authority ensuring all internal warehouses and external 3PL sites adhere to Good Distribution Practice (GDP), Good Manufacturing Practice (cGMP), FDA 21 CFR Part 11/820, and local EHS/OSHA regulations.
• Cold-Chain & Controlled Storage: Set global operating standards for temperature-controlled storage environments (-80°C, -20°C, 2–8°C, and ambient), mapping temperature validation protocols, excursion management, and emergency response workflows.
• Auditing & Corrective Actions: Drive root-cause analysis (CAPA) for warehouse-related deviations, inventory variances, or temperature excursions to maintain continuous audit readiness across the global logistics network.

3. Operational Excellence & 3PL Governance

• 3PL & Vendor Oversight: Define standard operating procedure (SOP) frameworks, service level agreements (SLAs), and Delegation of Authority (DoA) controls for outsourced warehouse operations and contract logistics providers.
• Lean Warehouse Transformation: Identify and execute continuous improvement initiatives using Lean principles (5S, Value Stream Mapping, Gemba) to maximize storage density, increase throughput, reduce pick errors, and drive down cost-per-pallet.
• Cross-Functional Alignment: Collaborate closely with Quality, Manufacturing, SHE, and Commercial Logistics to resolve operational friction and ensure new product launches seamlessly integrate into existing warehouse infrastructure.

Candidate Profile (Who You Are)

Education & Experience

• Education: Bachelor’s degree in Supply Chain Management, Industrial Engineering, Logistics, or a related technical discipline. Advanced degree (Master’s, MBA) preferred.
• Professional Experience: 8+ years of progressive leadership experience in Supply Chain, with a heavy emphasis on direct Warehouse Operations, Distribution Center Engineering, or Site Logistics within the Pharmaceutical, Diagnostics, Medical Device, or Biotech industries.
• Systems Expertise: Hands-on experience designing or implementing enterprise Warehouse Management Systems and automated material handling systems.

Technical & Regulatory Mastery

• Regulatory Knowledge: Deep, practical expertise in international GDP/GMP standards, temperature-controlled logistics, controlled substance handling, and warehouse safety/EHS regulations across major regions (EU, US FDA, China NMPA).
• Process Engineering: Demonstrated ability in warehouse layout design, capacity modeling, material flow optimization, and process mapping.

Leadership & Competencies

• Systems Thinker: Ability to analyze complex warehouse challenges, identify root causes, and build scalable, standardized solutions that balance compliance with operational speed.
• Enterprise Leader: Strong stakeholder management skills to influence cross-functional peers, lead global matrix projects, and coach local operational teams through large-scale process changes.