Sr. Director, GCP Quality Assurance

Role: Senior Director of Quality Assurance overseeing clinical trial quality and GCP compliance across Phase I–IV programs, providing risk-based QA oversight and strategic leadership. Responsibilities: develop and maintain clinical QA systems, generate/review documentation, lead audits of investigator sites and vendors, investigate and resolve quality issues, and support inspection readiness; contribute to establishing electronic quality reporting and oversee cross-functional quality support. Requirements: Bachelor's in a scientific discipline; 15+ years in biotech/pharma/clinical research industries supporting clinical development and GCP compliance; 12+ years of management experience; expertise in ICH-GCP, clinical quality systems, risk management, and audit processes; strong communication skills. HighValue: extensive experience in clinical quality oversight, audit management, document review, and inspection readiness; deep knowledge of GCP regulations, quality risk management, and electronic quality systems. WorkSetup: not specified; physical and medical surveillance requirements may apply.