Sr Manager, Supply Chain
Core
Leading end-to-end global clinical secondary packaging and labeling operations for investigational medicinal products across multiple studies.
Role type
Sr Manager, Global Clinical Supply Chain
Builds
Compliant, on-time delivery of packaged and labeled investigational medicinal products for global clinical trials.
Domain
Biopharmaceuticals / Clinical Development / GxP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical secondary packaging and labeling operations, GxP environment experience, Cross-functional collaboration, Risk assessment, Strategic planning, Vendor management, SOP authoring, Regulatory compliance, Process improvement, Project management
Preferred skills
Science degree (PharmD/PhD), Experience with clinical study designs and blinding, Global trial experience (Phase 1 to late phase), SAP/IQS/GPLM/QMS systems proficiency
Responsibilities
Interpret clinical study protocols to define packaging and labeling requirements, Develop and execute packaging strategies aligned with study timelines, Partner with Clinical Supply Planning, Quality, and Regulatory teams, Lead secondary packaging activities for study start-up and resupply, Manage relationships with internal and external packaging sites, Author SOPs and business process work instructions, Support regulatory filings and inspections, Maintain compliance for trial master file (TMF), Provide leadership and coaching to staff
Seniority
Senior, hands-on IC with people leadership accountabilities
