Senior Specialist, Training Coordination & Compliance Operations
Core
Coordinate GMP training and qualification programs for personnel in a Next Generation Biologics (NGB) facility to ensure compliance and readiness for manufacturing operations.
Role type
Senior Specialist, Training Coordination & Compliance Operations
Builds
Qualified, compliant workforce for biologics manufacturing processes
Domain
Biologics manufacturing / Pharmaceutical CMC / GMP Compliance
Deliverable
dashboards & analysis
Required skills
GMP training coordination, LMS administration, curriculum development, compliance monitoring, data reporting, document control, instructor-led training facilitation, remediation planning
Preferred skills
Dashboard design, digital learning technology implementation, regulatory inspection support, change management, process optimization
Technologies
Learning Management Systems (LMS), digital learning tools, electronic work instructions
Responsibilities
Coordinate GMP training and qualification programs; Partner with SMEs to establish role-based training requirements; Monitor training compliance and drive remediation; Manage training records and controlled documents; Administer LMS activities and reporting; Lead instructor-led training sessions; Prepare compliance metrics and qualification status reports
Seniority
Senior, hands-on IC