Quality Operations Program Manager
Core
Own the creation and lifecycle management of quality processes and records, providing oversight on regulated activities and deliverables for in-scope products and systems.
Role type
Quality Operations Program Manager (Process Owner)
Builds
Quality Management System (QMS) processes, documentation, and records
Domain
Life Sciences / Regulated Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS), electronic Document Management Systems (eDMS), electronic Quality Management Systems (eQMS), GxP regulations, process mapping, problem-solving
Preferred skills
Veeva Quality Cloud solutions, software development cycle (SDLC), computer systems validation (CSV)
Responsibilities
Act as subject matter expert for Document Control; Provide quality oversight on regulated activities and deliverables; Provide technical expertise and regulatory interpretation; Develop metrics to track effectiveness and productivity
Seniority
Mid-level, hands-on IC