Quality Audit Specialist

Job Summary

Managing client audits and internal assessments, the Quality Audit Specialist will work in a hybrid role based in Blue Bell, PA, primarily remotely, while ensuring compliance with clinical trial regulations and improving audit processes.

Key responsibilities

• Host and manage client audits from preparation through to post-audit follow-up
• Collaborate with management to address issues and findings from audits
• Conduct internal and vendor audits as required, ensuring adherence to best practices

Required qualifications

• Minimum of 3 years of relevant audit experience in clinical trials
• Comprehensive knowledge of FDA, MHRA, EMA regulations, and ICH Guidelines
• Previous experience in audit and inspection management
• Strong understanding of healthcare technology systems and software development
• Ability to analyze complex situations and recommend corrective actions