Spclst, Planning & Scheduling
Core
Execute and support GxP Quality System activities to ensure clinical supply operations are compliant, inspection-ready, and risk-based for Phase I–IV trials.
Role type
Specialist, Quality Compliance (Clinical Supply)
Builds
Compliant clinical supply operations across 60+ countries
Domain
Life Sciences / Clinical Trials / Quality Management Systems
Deliverable
dashboards & analysis
Required skills
GxP compliance, CAPA investigations, deviation analysis, risk management, data integrity (ALCOA+), cross-functional collaboration, analytical thinking
Preferred skills
Audit support, documentation lifecycle management, GMP electronic systems (MEDs, Veeva, TrackWise, LMS), Lean methodologies, Six Sigma
Technologies
MEDs, Veeva, TrackWise, LMS
Responsibilities
Execute compliance activities aligned with GxP procedures, support deviation investigations and CAPA activities, identify risks to compliance execution, review data for trending and performance monitoring, collaborate with cross-functional teams on QMS execution
Seniority
Junior, entry-level specialist
