Director, Global Quality Control

Role: Director of Global Quality Control supporting commercial readiness and ongoing QC operations for biologics in a fully outsourced manufacturing environment. Responsibilities: lead external QC laboratory oversight, develop and implement commercial QC strategies, oversee stability programs and specification lifecycle activities, manage analytical method lifecycle, support lot release and regulatory filings, and lead investigations into quality issues. Collaborate with cross-functional teams including Manufacturing, Regulatory, and Supply Chain to ensure compliance and supply continuity. Requirements: BS/MS in a scientific discipline; 10+ years in biotech/pharma QC/Analytical Sciences supporting GMP commercial products; strong expertise in biologics analytical methods, stability, and regulatory standards (FDA, EMA, ICH); experience managing external laboratory relationships and lifecycle management of specifications and methods. HighValue: biologics, GMP, commercial stability programs, regulatory compliance, external lab oversight, global market release, inspection readiness. WorkSetup: not specified; likely hybrid or remote with extensive external partner interaction.