Senior Director, Clinical Quality Assurance (CQA)

Role: Senior Director of Clinical Quality Assurance overseeing global clinical trials for late-stage biopharma candidates, including 4D-150 (wet AMD, Phase 3) and 4D-710 (cystic fibrosis gene therapy). Objectives: ensure compliance with GCP, ICH E6, and international regulations; lead quality strategy, risk management, and inspection readiness. Responsibilities: provide strategic QA leadership for multiple studies, develop and oversee quality plans, mentor QA staff, conduct risk-based GCP audits, and manage clinical study quality events; facilitate regulatory inspections and foster a culture of quality. Requirements: Bachelor’s in life sciences, nursing, pharmacy or related; 12+ years in regulated environments (biotech/pharma), with minimum 7 years in clinical QA, including GCP audits and inspections; experience leading quality strategy and vendor oversight for global trials. Preferred: advanced degree (MS, PharmD, PhD), ophthalmology experience. High-Value: involvement in late-stage (Phase 3) clinical development, international GCP compliance, inspection management, and cross-functional collaboration across Clinical, Regulatory, and Quality teams. Work setup: travel approximately 5%, physical activity predominantly sedentary, based in a hybrid or on-site environment.