Specialist, Operations (Project Management)
Core
Coordinate project activities, change controls, and incident investigations to support Pre-Approval Inspection (PAI) and filing readiness for manufacturing operations.
Role type
Specialist, Operations (Project Management)
Builds
Reliable, compliant delivery of high-quality materials and finished products
Domain
Pharmaceutical/Regulated Manufacturing
Required skills
Project coordination, Change control management, Incident writing, Schedule management, Risk management, Data integrity, Technical writing, Cross-functional collaboration, Microsoft Project, cGMP compliance
Preferred skills
Pharmaceutical manufacturing experience, Inspection readiness knowledge, Root-cause analysis, Lean Six Sigma, CAPA management
Technologies
Microsoft Project
Responsibilities
Track PAI deliverables and readiness trackers, Coordinate Change Review Board (CRB) logistics, Author incident and deviation records, Maintain project portfolios and status reports, Develop integrated project schedules, Support continuous improvement initiatives
Seniority
Mid-level, hands-on IC
