Lead, coordinate and perform corporate audits of the Quality Management System
Supply formal reports to the head of the audit program on site audits
Identify problematic areas during audits and assist with improvements
Support site inspection readiness through audits and informal reviews
Facilitate Global implementation of policies and clear application of auditing processes
Lead necessary corporate audits and work with Site Quality Representatives
Recommend additional work required with audited sites and participate in quality initiatives
Provide review and support to individuals or locations within the company

Experience with Corporate, divisional, site, supplier GMP, GDP, GLP or GCP audits
Related quality/operations GMP work experience in medical devices or pharmaceutical sector
Experience auditing technical files for conformance with EU regulations
Experience working for regulatory agencies or Notified Bodies preferred
Experience in sterilization, microbiology, statistical analysis, regulatory compliance, etc.
A working knowledge of different languages and willingness to travel widely
Bachelor’s degree in engineering, or sciences or relevant technical field required
Master’s degree preferred
Formal Auditor certification by a recognized body
Minimum 15 years of experience in auditing

Lead Auditor, Quality Compliance

Key skills