Principal Associate-Quality Auditor–GQA
Core
Conduct internal and external audits of GCP operations to ensure compliance with company standards, policies, and regulatory requirements for pharmaceutical development and clinical research.
Role type
Senior Quality Auditor (GCP)
Builds
Compliance assurance for GXP operations across pharmaceutical development, non-clinical, and clinical research.
Domain
Pharmaceutical / Clinical Research / Quality Assurance
Required skills
GCP regulations interpretation, audit planning and execution, risk assessment, compliance reporting, process analysis, regulatory guidance application
Preferred skills
Third-party organization management, Six Sigma project leadership, global team collaboration, change management
Technologies
Audit tools, databases, quality management systems
Responsibilities
Schedule, prepare, conduct, and report GQA audits of GCP operations; lead risk assessments for annual audit plans; interpret corporate and regulatory GCP requirements; prepare and review quality standards and policies; analyze audit findings and trends; support auditor training and qualification.
Seniority
Senior, hands-on IC
