Vaxcyte - Sr. Director, Quality Assurance for Quality Control

• Bachelor’s degree in Biochemistry, Chemistry, or a related field with 15+ years of relevant industry experience. Other combinations of education and/or experience may be considered. • Thorough knowledge of applicable FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines, along with proven expertise in applying these regulations to develop practical solutions and phase-appropriate analytical strategies. • Experience working with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment. • Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines. • Excellent written and verbal communication skills, including the ability to work effectively in cross-functional teams. • Previous experience in validation and transfer of analytical assays. • Demonstrated ability to build and develop high-performing QA teams and influencing cross-functional and executive stakeholders in a fast-paced commercial-stage biotech company. • Knowledge and experience in Risk Management principles. • Knowledge in both clinical and commercial product desired. • Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process. • Ability to work globally with CMOs in different countries and continents. • Experience managing geographically distributed QA teams across multiple sites or countries, with the ability to build cohesive quality culture and consistent GMP standards across locations. • Experience in BLA submission and commercial launch is highly desirable • Reports to: Executive Director, Quality Assurance • Reports • Location: Raleigh, NC • Location: • Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote