SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Vaxcyte, a clinical-stage vaccine innovation company, is seeking a Manager of Supplier & Internal Auditor to support the Quality Assurance organization. This role is responsible for planning, executing, and managing supplier and internal audits to assess compliance with global regulations, industry standards, and internal quality systems.
Key responsibilities include conducting on-site and remote supplier audits to evaluate compliance with applicable regulations and contractual quality requirements; preparing audit agendas, reports, and documentation; reviewing supplier responses to audit observations and CAPA plans; and collaborating with cross-functional teams (Technical Operations, Supply Chain, Regulatory, Quality Systems) to assess findings and risk.
For internal audits, the role will execute audits of quality systems and operational processes to assess compliance with GMP, GLP, GCP, ICH, and ISO 13485 standards; support development and maintenance of the internal audit program with risk-based planning; identify compliance gaps and improvement opportunities; and document observations clearly while supporting follow-up remediation activities.
The position also involves ensuring audit activities comply with regulatory requirements and industry best practices, supporting inspection readiness, contributing to development and review of quality procedures, and providing guidance and training to internal stakeholders on audit processes and compliance requirements.
Required qualifications include a Bachelor's degree in Life Sciences or related field, 5+ years of Quality Assurance, auditing, or compliance experience in pharmaceutical, biotechnology, or medical device industries, current auditor certification (ASQ CQA or equivalent), strong working knowledge of GMP, GLP, GCP, ICH guidelines and ISO 13485, demonstrated experience conducting supplier and internal audits, excellent written and verbal communication skills, strong organizational abilities, and willingness to travel. Vaccine experience is preferred.
