Vaxcyte · 2 months ago
Manager, Quality Assurance, Stability
San Carlos, California, United States
Full-time
Hybrid
Mid, Senior Level
$151K/yr - $176K/yr
5+ years expVaxcyte is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to combat bacterial diseases. They are seeking a QA Manager to oversee the stability program for their products, which includes reviewing stability protocols, managing QA oversight of studies at CMOs and CTLs, and ensuring compliance with quality standards.
BiopharmaBiotechnologyHealth Care
Responsibilities
QA Representative for quality management of the stability studies for Vaxcyte products
Key participant in quality team focused on the oversight of stability studies at CMOs and CTLs
Review and approval of stability protocols and reports
Review and approval of stability data and release data, as required
Review and approval of expiry and retest documentation for Vaxcyte products
QA representative for change controls, deviations and CAPAs associated with the stability program
Work closely with Stability, Project Management team, other functional areas, and external vendors for management of routing, revisions, approval, and filing of Stability documents in Veeva (electronic document control system) within defined timelines
Develop, implement and maintain procedures and policies
Support process improvement initiatives
Review and assess temperature excursions
Represent QA at internal and external cross functional tactical team meetings
Interact with key stakeholders to develop solutions to complex issues
Promote a quality mindset and quality excellence approach to all activities
May participate in compliance audits as required
Escalate issues impacting the safety, efficacy and shelf-life of stability material to appropriate management
Qualification
Required
BS or BA with minimum 5 years of relevant industry experience. Other combinations of education and/or experience may be considered
Demonstrate in-depth knowledge of GMPs, FDA regulations and ICH guidelines
Knowledge in both clinical and commercial product desired
Demonstrate excellent verbal, written, and interpersonal communication skills, collaborative approach essential
Demonstrate experience leading and contributing through influence and working in cross functional teams
Experience working with Contract Manufacturing Organizations
Strong sense of ownership for areas of responsibilities
Preferred
Knowledge of JPM, NovaStability and Veeva is desired
Benefits
Comprehensive benefits
Equity component
Company
Vaxcyte
Vaxcyte focuses on developing vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide.
201-500 employees
H1B Sponsorship
Vaxcyte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (7)
2023 (5)
2022 (7)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$3.85BKey Investors
CARB-XTPG GrowthAbingworth
2024-09-04Post Ipo Equity· $1.5B
2024-01-30Post Ipo Equity· $862.5M
2023-04-19Post Ipo Equity· $500M
Leadership Team
Andrew Guggenhime
President & Chief Financial Officer
Jeff Fairman
Founder and Vice President, Research
Recent News
2025-12-09
Company data provided by crunchbase