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