Vaxcyte · 2 days ago
Manager, Supplier & Internal Auditor
San Carlos, California, United States
Full-time
Hybrid
Mid, Senior Level
$153K/yr - $178K/yr
5+ years expVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. The Manager Supplier & Internal Auditor will support the Quality Assurance organization by planning, executing, and managing supplier and internal audits to ensure compliance with global regulations and internal quality systems.
BiopharmaBiotechnologyHealth Care
Responsibilities
Plan, schedule, and conduct supplier audits (on-site and remote) in support of supplier qualification and ongoing oversight programs
Evaluate supplier compliance with applicable regulations, standards, and contractual quality requirements
Prepare audit agendas, audit reports, and documentation in accordance with internal procedures and regulatory expectations
Review and assess supplier responses to audit observations, including corrective and preventive action (CAPA) plans, and verify effectiveness
Collaborate with cross-functional stakeholders (e.g., Technical Operations, Supply Chain, Regulatory, Quality Systems) to assess audit findings and risk
Execute internal audits of quality systems and operational processes to assess compliance with GMP, GLP, GCP, ICH, ISO 13485, and internal policies and procedures
Support the development and maintenance of the internal audit program, including risk-based audit planning and scheduling
Identify compliance gaps, trends, and opportunities for continuous improvement
Document audit observations clearly and objectively and support follow-up activities to ensure timely and effective remediation
Ensure audit activities are conducted in accordance with applicable regulatory requirements and industry best practices
Support inspection readiness by maintaining audit documentation and providing audit support during regulatory inspections as needed
Contribute to the development, review, and improvement of quality procedures related to auditing, supplier management, and compliance
Provide guidance and training to internal stakeholders on audit processes, regulatory expectations, and compliance requirements
Qualification
Required
Bachelor's degree in Life Sciences or a related field
5+ years of experience in Quality Assurance, auditing, or compliance within the pharmaceutical, biotechnology, or medical device industry. Other combinations of education and/or experience may be considered
Current auditor certification (e.g., ASQ Certified Quality Auditor (CQA) or equivalent)
Strong working knowledge of GMP, GLP, GCP, ICH guidelines, and ISO 13485 requirements
Demonstrated experience conducting supplier and/or internal audits
Strong written and verbal communication skills, with the ability to clearly document audit observations and communicate risk
Excellent organizational skills, attention to detail, and ability to manage multiple audits and priorities
Ability to work independently while collaborating effectively in a cross-functional environment
Ability to travel
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