Vaxcyte

Vaxcyte

Executive Director Quality Assurance, External Manufacturing

San Carlos, California, United States · Director

Sponsorship not specified$300k-$350kDetected 29 days ago
Performance ManagementGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingGxP

About the role

  • Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.
  • Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.
  • Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

Responsibilities

  • Own quality performance across the external network, ensuring compliance, supply continuity, and effective management of quality risk, with escalation of critical risks to VP-level as appropriate.
  • Establish and maintain strategic partnerships with external partners, driving accountability, performance management, and continuous improvement.
  • Lead quality governance across the external network, including KPIs, escalation pathways, and risk-based oversight models focused on critical processes and high-risk partners.
  • Oversee and drive resolution of complex, cross-organizational quality issues, ensuring robust investigations, root cause analysis, and sustainable CAPAs.

Requirements

  • Deep expertise in GMP regulations, FDA and global regulatory expectations, and ICH guidelines
  • Proven track record of leading complex external quality networks, driving performance and outcomes without direct authority
  • Strong background in risk management and quality systems, with the ability to apply risk-based decision-making in a GxP environment

Compensation

  • $300,000 - $350,000 (SF Bay Area). Salary ranges for non-California locations may vary.
  • This role is not eligible for relocation assistance.
  • The compensation package will be competitive and includes comprehensive benefits and an equity component.

Company info

  • This role is not eligible for relocation assistance.
  • We are an equal opportunity employer.
  • All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
  • Join our Mission to Protect Humankind!

This listing is sourced directly from Vaxcyte's careers page and normalized into a canonical job model.