Summary:Vaxcyte is seeking a Manager Supplier & Internal Auditor to support the Quality Assurance organization through the planning, execution, and management of supplier and internal audits. This role will be responsible for assessing compliance with applicable global regulations, industry standards, and internal quality systems to ensure the integrity of Vaxcyte's operations and external partnerships. The ideal candidate is a certified auditor with strong working knowledge of GMP, GLP, GCP, ICH, and ISO 13485 requirements and experience auditing within the pharmaceutical, biotechnology, or medical device industries.
Essential Functions:- Supplier Audits
- 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.
- Internal Audits
- 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.
- Compliance & Quality Systems
- 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.
Requirements:- 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.
- Vaccine experience is preferred.
- 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.
Reports to: Director, Quality Assurance, Vendor Management
Location: Hybrid in San Carlos, CA; Open to remote
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Hybrid (minimum of 3 days per week onsite)/Open to Remote
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $151,000 - $176,000 (SF Bay Area). Salary ranges for non-California locations may vary.
