Quality Audit Specialist

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