Director QA Operations
Core
Provide quality support and oversight for drug substance manufacturing operations, ensuring compliance with FDA and international regulatory requirements.
Role type
Director, Quality Assurance Operations
Builds
Drug substance manufacturing processes including cell culture, centrifugation, chromatography, UFDF, and aseptic dispensing
Domain
Biopharmaceuticals / Drug Substance Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Operations leadership, manufacturing process oversight, regulatory compliance (FDA), team management, project management, CAPA tracking, audit readiness, process improvement, cross-functional collaboration
Preferred skills
Experience in late-stage or early-stage start-up biologics companies
Technologies
GMP, batch record review, deviation management, SOP development
Responsibilities
Build and execute business strategy for the QA department; lead and develop high-performing teams; oversee in-process testing and line clearance; manage cross-functional projects within budget and timeline; represent the company during regulatory inspections; drive process improvements and continual improvement initiatives
Seniority
Director, strategic leadership with hands-on operational oversight
