US Kit Production Manager
Core
Lead clinical trial kit production and distribution, overseeing internal operations and third-party vendors to ensure accurate, on-time delivery compliant with study protocols and regulations.
Role type
Manager, clinical trial logistics and kit production
Builds
Clinical trial specimen collection kits and sample kits for investigator sites
Domain
Clinical research / Clinical trial logistics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team leadership and development, Quality Management System (QMS) oversight, Root cause analysis and CAPA management, Vendor/outsourced provider management, Lean Six Sigma methodologies, Inventory and supply chain management, Cross-functional collaboration, Regulatory compliance (GCP)
Preferred skills
Master's degree in Business/Supply Chain, APICS/ASCM certifications (CPIM/CSCP), PMP certification, Lean Six Sigma Green/Black Belt, ERP system proficiency
Technologies
Microsoft Dynamics, SAP, inventory/warehouse management systems
Responsibilities
Manage daily departmental performance and team operations; Own Quality Events and QMS elements; Lead stand-up of new production lines; Manage outsourced kitting providers and SLAs; Coordinate urgent builds and shipments; Contribute to budget planning and continuous improvement projects.
Seniority
Manager, hands-on leadership