Associate Director, Quality Change Management
Core
Leads quality change control governance to ensure changes are risk-assessed, compliant, and implemented with appropriate controls across internal operations and external partners.
Role type
Associate Director, Quality Change Management
Builds
Production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Domain
Biopharmaceuticals / MASH therapeutics / GMP QA
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Change control governance, risk-based impact assessment, implementation readiness criteria, cross-functional leadership, escalation, executive-ready risk communication, partner governance, performance management, inspection readiness traceability, documentation rigor, Veeva Vault Quality proficiency
Preferred skills
Pharmaceutical/biotech post-approval change governance, external manufacturing changes, eQMS configuration, workflow optimization
Technologies
Veeva Vault Quality
Responsibilities
Own change control standards, templates, decision rights, and review cadences; Coordinate change reviews across Quality/CMC/MSAT/Supply Chain and external partners; Own change KPIs and continuous improvement actions; Ensure inspection-ready change documentation, traceability, and evidence retrieval
Seniority
Senior, hands-on IC
