Senior Director, Quality

Engaging Summary Ready 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.

Location: Emeryville, CA — Onsite

• 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 visibility

• 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 needs

• 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 partner

Send resume to and reference Job #19676.