Pharmaceutical/Biologics R&D Quality Lead

Role: R&D Quality Lead for pharmaceutical, biologic, and combination products, focusing on quality strategy development and compliance across research, development, regulatory, clinical, and manufacturing functions. Responsibilities: provide GMP and R&D quality oversight for outsourced activities, review and approve protocols, reports, and CMC documentation, support GMP systems, ensure regulatory compliance, participate in audits, and communicate project status. Requirements: Bachelor's in a scientific discipline; 12+ years in pharma/biologics industry, or 8+ years with a Master's; extensive experience in R&D quality, GMP compliance, CMC, clinical supply, and regulatory support; knowledge of global GMP regulations (FDA, EMA, ICH). HighValue: biologics/pharmaceuticals, development stage (pre-approval), CMC, GMP, regulatory submissions, supplier oversight, audit experience. WorkSetup: Aliso Viejo, CA.