Senior Director, QualityLocation:Emeryville, CA — OnsiteEngaging SummaryReady to lead Quality for a fast-scaling biologics innovator? My client is building the next generation of antibody development and CDMO excellence — and they need a visionary Senior Director to elevate their Quality organization into a world-class engine. If you thrive in high-growth environments, love architecting Quality systems from strategy to execution, and bring deep biologics/GxP expertise, this role puts you at the center of breakthrough science and global impact.Why You Should Apply Shape enterprise-wide QA/QC/QE strategy in a high-visibility leadership role Lead inspection readiness and partner directly with FDA/EMA Build and scale a high-performing Quality organization Influence antibody development, biologics manufacturing, and tech transfer Competitive salary, strong benefits, and onsite leadership visibilityWhat You’ll Be Doing Driving Quality strategy, systems, and culture Leading QA/QC/QE teams and quality operations Managing audits, compliance, and regulatory interactions Overseeing QMS, CAPA, deviations, document control Supporting CMC, manufacturing, and client-facing quality needsAbout You 15+ years QA in pharma/biopharma; 5+ years leadership Extensive GxP and global regulatory expertise CDMO or biologics background preferred Strong communicator and cross-functional partnerHow To ApplySend resume to and reference Job #19676.