Director, Quality Operations
Core
Functional quality leader for multiple business units ensuring worker safety, quality, environmental compliance, and production/supply chain needs are met while coaching shop floor teams.
Role type
Director, Quality Operations (Manufacturing)
Builds
Production operations with Right-First-Time manufacturing outcomes
Domain
Biopharma / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP manufacturing, aseptic processing, industrial management, budget management, team leadership, regulatory compliance (CFR 210/211, 820, cGXP, ICH Q8/Q9/Q10, EU/Eudralex), production operations knowledge, aseptic operations, microbiology, analytical chemistry, validation
Preferred skills
Contract Manufacturing experience, supervisor/manager experience
Technologies
GMP systems, QMS systems, batch record systems, deviation management tools
Responsibilities
Monitor QMS execution to maximize employee focus and enable Right-First-Time manufacturing; maintain systems for batch disposition tracking; administer shop floor GEMBAs and process observations; manage a team of Quality professionals across shifts; serve as primary contact for customer communications; develop and meet budgets; coach staff and ensure succession planning
Seniority
Director, strategic leadership with hands-on operational oversight