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 quality systems across manufacturing sites, development centers, contract manufacturers, laboratories, warehouses, and suppliers.
Domain
Pharmaceutical and medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP audit execution, regulatory compliance assessment, corrective and preventive action plan review, risk identification, training on audit activities, stakeholder communication, knowledge of evolving regulations
Preferred skills
Auditing experience, proficiency in additional languages (German, French, Italian, Chinese, Spanish)
Technologies
Computer system validation tools, quality management systems
Responsibilities
Plan and execute GMP audits, assess compliance with regulations and standards, document audit observations and reports, review corrective action plans, provide expert guidance and training, escalate critical compliance issues
Seniority
Senior, hands-on IC