Manager, Supplier & Internal Auditor
Core
Plan, execute, and manage supplier and internal audits to ensure compliance with global regulations and quality systems for a clinical-stage vaccine company.
Role type
Manager, Supplier & Internal Auditor
Builds
Supplier qualification programs and internal quality assurance systems
Domain
Biotechnology / Vaccine Development / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier audit planning and execution, Internal audit program management, CAPA verification, Regulatory compliance assessment, Risk-based audit planning, Cross-functional collaboration, Audit documentation and reporting, Training and guidance on compliance
Preferred skills
Vaccine development experience, Auditor certification (CQA or equivalent)
Technologies
GMP, GLP, GCP, ICH, ISO 13485
Responsibilities
Plan, schedule, and conduct on-site and remote supplier audits; Execute internal audits of quality systems and operational processes; Review and assess supplier responses to audit observations including CAPA plans; Support inspection readiness by maintaining audit documentation; Contribute to the development and improvement of quality procedures related to auditing; Provide guidance and training to internal stakeholders on audit processes
Seniority
Manager, hands-on IC