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Salary: USD 163,000 - 191,000 / annual
Vaxcyte is a clinical-stage vaccine innovation company developing high-fidelity vaccines to protect against bacterial diseases including invasive pneumococcal disease, Group A Strep, and Shigella. The company is guided by core values of rethinking convention, aiming high, leading with heart, and modeling excellence.
The Senior Manager, Clinical Quality Assurance will lead global investigations and support teams with CAPA (Corrective and Preventive Action) preparation in compliance with applicable regulations, guidelines, SOPs, and project-specific instructions. Key responsibilities include managing quality issues and serious breach investigations; reviewing and approving investigations, root cause analyses, CAPA plans, and effectiveness checks; tracking quality events from issues, audits, and inspections until closure; managing quality event updates in the electronic Quality Management System (eQMS); planning and conducting risk-based and for-cause audits of clinical investigator sites, CROs, and other GCP vendors; supporting regulatory agency inspection readiness activities including mock inspections and gap assessments; evaluating policies and procedures for regulatory compliance and recommending improvements; supporting QA initiatives and process improvement projects; promoting a quality mindset and excellence approach; and interpreting FDA regulations and ICH guidelines to implement compliant processes.
The role reports to the Senior Director of Clinical Quality Assurance and is based in San Carlos, CA with a hybrid work arrangement requiring a minimum of 3 days per week onsite. Travel up to 15% is required.
REQUIREMENTS:
- Bachelor's degree (BA or BS) in a related field
- Minimum 9 years of experience in Quality Assurance within clinical or pharmaceutical industry (other combinations of education and experience may be considered)
- Knowledge of QMS systems (Veeva preferred)
- GCP QA Certification preferred (RQAP-GCP or similar)
- Experience across all phases of clinical development
- Knowledge of applicable FDA regulations and ICH guidelines
- Proficiency in QA tools and software (Veeva preferred)
- Excellent communication and interpersonal skills with ability to work collaboratively with diverse teams
- Strong analytical and problem-solving skills with keen attention to detail
- Ability to travel up to 15%
