Senior Manager, Quality Assurance

Leading the quality function for assay validation, the fully remote Senior Manager, Quality Assurance will oversee analytical method lifecycle management supporting vaccine development programs, ensuring compliance and readiness for commercialization activities. Key Responsibilities: Lead quality oversight for assay validation, transfer, verification, and lifecycle management related to vaccine clinical development and commercialization Provide approval for validation protocols, reports, analytical control strategies, and lifecycle documentation Review analytical data packages and support product disposition decisions through data analysis and investigations Required Qualifications: Bachelor's or advanced degree in a scientific discipline 9+ years of GMP Quality experience in analytical method validation and commercialization activities in vaccines or biologics Strong understanding of analytical method qualification, validation, and lifecycle management Experience with regulatory submissions and health authority inspections Working knowledge of 21 CFR Parts 210 and 211, ICH Q2, and FDA analytical validation guidance