Global GMP Quality Auditor
Core
Plan, lead, and execute GMP audits across global operations and external partners to ensure compliance, quality, and patient safety.
Role type
Senior GMP Quality Auditor
Builds
Compliance assurance and risk mitigation across manufacturing sites, development centers, contract manufacturers, and suppliers
Domain
Pharmaceutical manufacturing and quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP audit planning and execution, regulatory compliance assessment, corrective and preventive action plan review, stakeholder communication, risk identification, training on audit activities
Preferred skills
Auditing experience, proficiency in additional languages (German, French, Italian, Chinese, Spanish)
Technologies
None stated
Responsibilities
Plan and execute GMP audits, assess compliance with regulations and standards, document audit observations and reports, review corrective action plans, provide training on audit activities, escalate critical compliance issues
Seniority
Senior, hands-on IC