Quality Operations Program Manager
Core
Own the creation and lifecycle management of quality processes and records within the Quality Management System (QMS) for document control.
Role type
Quality Operations Program Manager (Process Owner)
Builds
Quality processes, records, and regulated deliverables for life sciences product lines
Domain
Life Sciences / Regulated Quality Management
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), ISO9001, process mapping, problem-solving
Preferred skills
Veeva Quality Cloud solutions, software development cycle (SDLC), computer systems validation (CSV), ISO/IEC/IEEE/ITIL/ICH standards
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 system effectiveness and productivity
Seniority
Mid-level, hands-on IC