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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