GCP Clinical Auditor II (remote US)

Thermo Fisher Scientific seeks a GCP Clinical Auditor II to conduct internal and external audits ensuring compliance with regulatory guidelines and quality standards in clinical research. The role involves leading audits, assessing compliance issues, and supporting project teams from a remote US location with up to 50% travel.

Responsibilities

• Conduct and lead client, internal, and GCP audits supporting regulatory inspections
• Lead directed clinical site and facility audits; identify quality and compliance issues
• Provide GCP consultation and quality support to project teams and external clients
• Prepare comprehensive audit reports and present findings at departmental and client meetings
• Perform database audits, clinical study report reviews, and process improvement activities

Requirements

• Bachelor's degree or equivalent formal academic or vocational qualification
• 2-5 years of Quality Assurance experience in regulated industry
• Audit experience in clinical research or pharmaceutical sector preferred
• Detailed knowledge of Good Clinical Practice (GCP) and regional regulations
• Demonstrated experience leading project-based and internal GCP audits
• Root cause analysis and risk assessment capabilities
• Valid driver's license and ability to travel 25-50% within US

Compensation: $60,000-$90,000 USD annual salary, plus potential variable annual bonus