Associate Director, GMP QA Operations
Core
QA technical lead for external manufacturing and testing project teams, ensuring effective development and implementation of Quality Systems supporting GMP activities.
Role type
Associate Director, GMP QA Operations
Builds
Drug Substance and Drug Product for neuromuscular disease therapeutics
Domain
Biopharmaceuticals / Gene Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, CMO oversight, batch record review, CAPA management, change control, regulatory submissions, audit participation, quality metrics development
Preferred skills
Master's degree, CDMO experience, therapeutic industry knowledge
Technologies
GXP QA systems, FDA/EMA regulations
Responsibilities
Lead external manufacturing QA teams, oversee release activities for Drug Substance and Drug Product, lead quality investigations and CAPA, manage CMO quality agreements, participate in domestic and international audits, develop and monitor Quality Operations KPIs
Seniority
Senior, hands-on IC with leadership responsibilities