Senior Manager Quality Operations
Core
Establish and maintain Quality Operations systems to support Manufacturing, Technical Services, Donor Management, Supply Chain, and R&D for Clinical and Commercial products, ensuring compliance with GXP regulations.
Role type
Senior Manager, Quality Operations
Builds
Quality oversight systems, batch records, analytical data reviews, and product disposition processes
Domain
Biopharmaceutical manufacturing and regulatory compliance
Required skills
GXP regulations, FDA 21 CFR 210/211, team management, batch record review, analytical data review, donor/material hold management, COA creation, lot release scheduling, technical investigations, KPI metrics, electronic system design, process validation, technology transfer, CMO support, CAPA management
Preferred skills
Microbiology, 21 CFR 600/610, 21 CFR 820, ISO 13485
Technologies
Electronic batch record systems, quality management software
Responsibilities
Manage batch record issuance, review, and disposition; oversee Donor and Material Hold programs; manage incoming inspection and COA creation; establish lot release schedules; perform technical investigations on deviations and complaints; develop quality systems to prevent human error; approve labels and disposition finished products; support R&D from Phase 1 to commercialization; manage hiring, coaching, and development of direct reports
Seniority
Senior, hands-on IC with management responsibilities