Senior Director of Quality Assurance

Job Summary

To ensure compliance with global regulatory guidelines and support a pipeline of high-fidelity vaccines, the remote Senior Director of Quality Assurance will manage QA oversight of QC activities, provide direct support to analytical operations in Switzerland, and lead the San Carlos-based QA team while collaborating with internal and external partners.

Key responsibilities:

• Lead quality oversight activities related to method validation, release, and in-process testing for Drug Substance and Polysaccharide
• Serve as the primary liaison within Vaxcyte QA and with outside collaborators, building partnerships that support analytical needs
• Drive resolution of quality performance issues with contract manufacturers and testing organizations

Required qualifications:

• Bachelor's degree in Biochemistry, Chemistry, or a related field with 15+ years of relevant industry experience
• Thorough knowledge of FDA, EU, and ICH regulatory guidelines for method qualification and validation in biologics and vaccines
• Experience working with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment
• Demonstrated ability to build and develop high-performing QA teams and influence cross-functional stakeholders
• Experience managing geographically distributed QA teams across multiple sites or countries