Senior Manager, GMP QA Operations
Core
Oversees quality activities for contract manufacturing organizations (CMOs) to ensure compliance with FDA and global GMP regulations for clinical and commercial product disposition.
Role type
Senior Manager, GMP QA Operations
Builds
Compliant clinical trial supply and commercialization-ready drug products
Domain
Biopharmaceuticals / Gene Therapy / Neuromuscular Diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP QA operations, CMO oversight, deviation investigations, CAPA implementation, batch record review, change management, regulatory compliance (FDA/EMA), quality metrics/KPIs, cross-functional collaboration
Preferred skills
Master's degree, experience with CDMO organizations, therapeutic industry knowledge, Veeva/SmartSheet proficiency
Technologies
Veeva, SmartSheet, MS Office
Responsibilities
Oversees release activities for Drug Substance and Drug Product including batch record review and disposition decisions; Assembles product disposition packages and Certificates of Conformance; Represents GMP QA in interactions with CMOs including governance meetings; Leads GMP investigations including root cause analysis and CAPA development; Develops and tracks Quality Operations metrics (KPIs) for Management Review
Seniority
Senior Manager, hands-on leadership
