Quality Operations Program Manager
Core
Own the creation and lifecycle management of quality processes and records, providing oversight on regulated activities like validation testing and product releases.
Role type
Quality Operations Program Manager (Process Owner)
Builds
Quality Management System (QMS) processes and records for life sciences products and systems
Domain
Life Sciences / Regulated Quality / GxP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS) expertise, electronic Document Management Systems (eDMS), electronic Quality Management Systems (eQMS), GxP regulations (GMP, GCP, 21CFR 11, ICH Q10, QSR), process mapping, problem-solving
Preferred skills
Veeva Quality Cloud solutions, software development cycle (SDLC), computer systems validation (CSV), ISO/IEC/IEEE/ITIL/ICH standards
Technologies
Veeva Quality Cloud, eDMS, eQMS
Responsibilities
Create and manage quality processes and records, provide quality oversight on regulated activities, offer technical expertise and regulatory interpretation, develop metrics to track system effectiveness
Seniority
Mid-level, hands-on IC
