Director Failure Investigation
Core
Leading failure investigation strategy, execution, and continuous improvement in a high-volume, regulated manufacturing environment to ensure compliant root cause analysis and product quality.
Role type
Director, Failure Investigation
Builds
Finished Goods, Consumables, and Reagents quality and process reliability
Domain
Life sciences diagnostics and biotechnology manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Corrective and Preventive Actions (CAPA), FDA/ISO/GMP compliance, Lean Manufacturing, Cross-functional collaboration, Team leadership, KPI monitoring, Risk management
Preferred skills
Good Manufacturing Practices (GMP) knowledge, High-volume manufacturing experience, Life science domain expertise
Responsibilities
Set strategy and priorities for failure investigations; Lead complex investigations including containment and impact assessment; Partner with cross-functional teams to resolve recurring issues; Ensure compliance with FDA, ISO, GMP, and OSHA requirements; Drive continuous improvement to reduce repeat failures; Lead, coach, and develop technical staff; Communicate investigation status and risks to leadership.
Seniority
Director, strategic leadership and team management
