Sr. Clinical QA Auditor

The Sr. Clinical QA Auditor will support and lead quality assurance activities across clinical trials within a fast-paced CRO environment, serving as a subject matter expert in GCP compliance, driving audit strategy, inspection readiness, and continuous quality improvement.

Requirements

• Lead and execute GCP audits
• Design and lead mock FDA/EMA inspections and inspection readiness initiatives
• Provide onsite audit support during regulatory inspections
• Provide support and guidance on GCP regulations and quality improvement initiatives
• Perform and oversee TMF quality reviews and audits
• Identify compliance risks, trends, and gaps
• Act as a trusted advisor to sponsors
• Contribute to the development and continuous improvement of QA processes, SOPs, and audit methodologies
• Participate in review of internal and external Quality Issues (QIs) and Corrective and Preventive Action (CAPA) plans