Sr. Director, Quality Assurance for Quality Control

Role: Senior Director of Quality Assurance overseeing analytical operations for Vaxcyte's vaccine pipeline, with dual responsibilities supporting global compliance and managing QA teams in Switzerland and California. Objectives include ensuring GMP compliance for QC activities related to polysaccharides and drug substances, partnering with internal teams and external CROs/CTLs, and supporting regulatory submissions. Responsibilities encompass leading method validation, review of GMP documentation, managing vendor performance, investigating deviations, and maintaining audit readiness. Requirements: Bachelor's in Biochemistry, Chemistry, or related field, with 15+ years of industry experience, deep knowledge of FDA, EU, ICH regulations, and expertise in biologics/vaccine quality control, validation, and transfer of analytical assays. Preferred: Experience in BLA submissions, vaccine development, and cross-site global QA management. High-value specifics: biologics/vaccine modality, GMP compliance, analytical methods, regulatory interaction, and international vendor oversight. Reports to: Executive Director, Quality Assurance. Work setup: Remote in Raleigh, NC with a competitive salary range of $229K–$268K.