Vaxcyte · 18 hours ago
Senior Manager, Quality Assurance, Drug Product
San Carlos, CA
Contract
Hybrid
Senior Level, Lead/Staff
$166K/yr - $193K/yr
8+ years expVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. The Senior Manager, Quality Assurance, Drug Product will oversee QA activities related to manufacturing, batch disposition, deviations, and risk management, while actively participating in audits and continuous improvement initiatives.
BiopharmaBiotechnologyHealth Care
Responsibilities
Provide Quality Assurance oversight of Contract Manufacturing Organizations
Represent QA at internal cross functional team meetings and at Joint Project Team meetings
Lead batch disposition activities such as review of executed batch records, environmental monitoring and quality control data
Review and approve documentation such as master batch records, deviations, risk assessments, change controls, and CAPAs
Lead deviation and product complaint investigations
Drive resolution of quality performance issues with the contract manufacturer
Support validation activities
Identify opportunities to streamline QA processes and systems
Champion initiatives to enhance quality culture and operational excellence across the organization
Interact with key stakeholder to develop solutions to complex issues
Participate in compliance audits as required (health authority and contract manufacturer)
Promote a quality mindset and quality excellence approach to all activities
Mentor and coach QA staff to strengthen technical capabilities and regulatory compliance mindset
Qualification
Required
Bachelor's degree in Chemistry, Biology, Pharmacy, Engineering, or a related field
Minimum of 8 years of experience in quality assurance, batch record review, manufacture, or quality systems management within the pharmaceutical, biotechnology, or life sciences industry. Other combinations of education and/or experience may be considered
Strong knowledge of cGMP, ICH guidelines, FDA/EMA regulations, and other international pharmaceutical quality standards
Knowledge and experience in Risk Management principles
Experience in both clinical and commercial parenteral drug product required
Strong Management and process improvement skills
Demonstrated experience managing batch record review, deviations and change management
Demonstrate experience in annual product reports
Great organization skills and have an attention to details
In-depth understanding of aseptic manufacturing (biologics) operations
Ability to prioritize multiple assignments and changing priorities
Excellent problem-solving skills and the ability to manage complex investigations and root cause analyses
Strong written and verbal communication skills, with the ability to clearly present quality issues to cross-functional teams
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
Pharma Letter
2026-01-25
2026-01-23
Company data provided by crunchbase