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Summary:

This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines. Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a Senior Director. This role carries dual accountability: providing direct QA support to the analytical operations based in Switzerland, while also managing the San Carlos-based QA team responsible for oversight of smaller-scale analytical activities. The Senior Director will be expected to operate effectively across both sites, navigating the distinct regulatory environments and operational cadences of each. The primary responsibility will be the QA oversight of QC activities associated with Vaxcyte's PCV Polysaccharides and Drug Substances. The Senior Director will work closely with internal teams (Process Development, MSAT, Quality Control, Regulatory, and Stability) and external partners (CDMOs and CTLs) to maintain the compliance of the analytical program.

Essential Functions:

• 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 for relevant programs.
• Represent QA at internal and external cross functional team meetings.
• Lead review and approval of internal and external GMP documentation for compliance, including specifications, Certificates of Analysis, validation reports, deviations, change controls, risk assessments, and CAPAs as they relate to polysaccharides and drug substance; apply technical and compliance expertise to critically evaluate reference standards, test methods, protocols, and raw data packages from CMOs and contract testing laboratories.
• Partner with QC, vendor management, and contract labs to set key performance indicators for monitoring vendor effectiveness.
• Drive resolution of quality performance issues with contract manufacturers and testing organizations
• Review Quality Agreements and regulatory documentation as required.
• Lead quality investigations of testing deviations and OOS.
• Contribute to regulatory filings, respond to questions from health authorities, and ensure quality of documentation used in support of regulatory submissions.
• Take part in audit preparations and help ensure ongoing readiness.
• Develop, review, and update GMP-related internal policies and procedures as necessary.
• Champion a culture of quality excellence and continuous improvement by proactively identifying systemic gaps, driving implementation of sustainable solutions, and establishing performance standards that elevate GMP compliance across internal teams and external partners.

Requirements:

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

Location: Raleigh, NC

Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote

Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range:  $229,000 - $268,000 (North Carolina)