Job Summary:

Our client, an innovator in the medical device and cleanroom solutions space is seeking a WMS Project Manager to lead the end-to-end implementation of a Warehouse Management System and enhance cold-chain logistics across their global CMO network. The role requires hands-on involvement throughout the full project life cycle, from requirements gathering through design, validation, deployment, and continuous improvement, ensuring alignment with ISO 13485, GDP, and industry best practices.

Key Responsibilities

Lead and consult across the entire WMS project life cycle—including planning, system selection, configuration, validation (IQ/OQ/PQ), and go-live support.
Collaborate with internal teams and CMOs to design and implement compliant cold-chain logistics processes.
Ensure regulatory compliance with ISO 13485, FDA QSR, GMP, and GDP across warehousing and transportation activities.
Develop SOPs, training materials, and risk assessments related to warehouse and temperature-controlled operations.
Drive integration between WMS, ERP, and temperature-monitoring systems.
Support vendor and CMO audits, qualification, and ongoing performance evaluation.
Monitor cold-chain KPIs (e.g. temperature excursions, transit time) and identify areas for improvement.
Provide subject matter expertise on supply chain best practices and regulatory trends in Medtech and pharmaceutical logistics.

Essential Requirements

Bachelor’s degree in supply chain, Engineering, Life Sciences, or related field (master’s preferred).
10+ years’ experience in supply chain roles with proven project life-cycle experience, particularly in WMS implementation and cold-chain logistics.
Strong knowledge of ISO 13485, GMP/GDP, and FDA regulatory requirements.
Demonstrated experience working with CMOs or third-party logistics providers in a regulated environment.
Familiarity with validated cold-chain solutions, packaging, and monitoring systems.
Proficiency in ERP/WMS platforms, Excel, and data reporting tools.
Experience with system validation (IQ/OQ/PQ) and change control processes.
Excellent communication, stakeholder management, and cross-functional collaboration skills.
Willingness to travel up to 15% for site visits, vendor audits, and project implementation support.

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