Clinical Quality Audits Director

A company is looking for an Associate Director/Director, Clinical Quality Audits. Key Responsibilities: Lead the Clinical Quality Assurance Audit Program and manage a team of auditors Ensure robust collaboration with Clinical Operations for planning and conducting site audits Support internal audit programs and develop quality metrics in partnership with key stakeholders Required Qualifications: BA/BS degree required; advanced degree preferred Minimum of 8+ years in the bio-pharmaceutical R&D industry, with 4 years in Clinical Quality Assurance At least 2 years of audit management experience, including leadership of teams or projects Demonstrated knowledge of FDA regulations and ICH guidance for relevant activities Experience in conducting audits and preparing for health authority inspections

Mar 24, 2025 - 21:31

A company is looking for an Associate Director/Director, Clinical Quality Audits. Key Responsibilities: Lead the Clinical Quality Assurance Audit Program and manage a team of auditors Ensure robust collaboration with Clinical Operations for planning and conducting site audits Support internal audit programs and develop quality metrics in partnership with key stakeholders Required Qualifications: BA/BS degree required; advanced degree preferred Minimum of 8+ years in the bio-pharmaceutical R&D industry, with 4 years in Clinical Quality Assurance At least 2 years of audit management experience, including leadership of teams or projects Demonstrated knowledge of FDA regulations and ICH guidance for relevant activities Experience in conducting audits and preparing for health authority inspections