Quality Management System
Core
Central owner of QMS policies, procedures, and records ensuring audit readiness for multi-framework compliance (SOC 2, ISO, FedRAMP, GxP) and serving as the named quality representative for life-sciences customers.
Role type
Senior IC Quality Management System Manager
Builds
A living QMS embedded in engineering workflows, evidence collection pipelines, and audit response artifacts for global organizations.
Domain
Software Engineering Operations / Identity Governance & Administration (IGA) / Life Sciences Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS governance, multi-framework audit coordination, CAPA management, root-cause analysis, engineering tooling fluency, cross-functional communication
Preferred skills
ISO 9001 certification program leadership, GxP/GAMP 5 vendor qualification, evidence automation, AI-assisted workflow design
Technologies
Jira, Confluence, CI/CD, ServiceNow, AWS
Responsibilities
Maintain and govern QMS policies and records; Drive readiness for SOC 2, ISO 27001, FedRAMP, and other certifications; Lead ISO 9001 certification program; Operate evidence and control environment; Run internal audit and CAPA programs; Partner with GRC and customer-facing teams
Seniority
Senior, hands-on IC
