Director, GCP Quality Assurance

Role: Lead GCP Quality Assurance for clinical development, overseeing audit activities to ensure compliance with global regulatory standards. Responsibilities: manage internal and external GCP audits of CROs, investigator sites, and vendors; develop audit reports, quality agreements, and SOPs; support inspection readiness and regulatory inspections; monitor GCP compliance metrics; advise cross-functional teams on GCP regulations; drive continuous improvement of quality systems. Requirements: Bachelor’s in Life Sciences or related field; 10+ years in pharmaceutical/biotech industry; 5+ years in GCP QA, auditing, and compliance; experience as a Lead Auditor; strong knowledge of ICH-GCP, FDA, EU regulations; experience with CRO/vendor audits and inspection support. Preferred: SQA, ASQ, or Lead Auditor certification; experience conducting global audits across US, EU, UK, Japan; familiarity with clinical service providers such as eCOA, CSV, and data management. HighValue: GCP audit focus, clinical trial oversight, global regulatory compliance, experience with investigator sites and vendors. WorkSetup: remote with ability to travel overnight as needed; salary range $165,900—$207,400 USD.