Director, GCP Quality Assurance

Role: Lead GCP Quality Assurance for clinical development at Acadia Pharmaceuticals, ensuring compliance across global GCP regulations and quality systems. Responsibilities: plan and conduct internal/external audits of CROs, vendors, and investigator sites; develop audit reports and track corrective actions; manage GCP quality agreements; support inspection readiness and regulatory inspections; oversee GCP quality documentation and metrics; enhance quality systems and processes. Requirements: Bachelor's in Life Sciences or related field; 10+ years in pharma/biotech with 5+ years in GCP QA and auditing; strong knowledge of ICH-GCP, FDA, EU regulations; experience as a Lead Auditor for GCP audits; supporting regulatory inspection processes. Preferred: SQA, ASQ, or Lead Auditor certification; experience with international audits (US, EU, UK, Japan); familiarity with clinical service providers, eCOA, CSV, and data management. HighValue: GCP compliance, audit leadership, global regulatory standards, supporting clinical trial phases, vendor oversight, inspection readiness. WorkSetup: Not specified; travel likely required.