About this role

Conduct risk-based end-to-end GCP audit activities
Provide GCP subject matter expertise and lead/influence the Clinical Development organization
Facilitate and review audit and inspection responses
Contribute to the development and interpretation of global QA policies
Support project teams in CAPA plan creation and execution
Lead or support reporting of quality metrics and trends via Monthly Reports
Manage or participate in global Quality initiatives aimed at improving compliance and efficiency
Deliver audit-related training

Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline
Minimum 8 years of experience in a regulated environment, including GxP roles
Fluent in English, written and verbal
Demonstrated regulatory expertise with detailed knowledge of GCP and applicable global regulations
Experienced Lead GCP Auditor with strong critical thinking and risk-based assessment skills
Strong strategic communication skills with clients and internal stakeholders
Experience leading or contributing to quality and process improvement initiatives reducing inspection risks and strengthen inspection readiness.

QA Compliance Lead Auditor – GCP Auditor

Key skills