Senior Director, Quality Assurance - Gene Therapy

Role: Senior Director, Quality Assurance overseeing gene therapy product programs from toxicology through Phase 3 and commercialization. Responsibilities: lead GMP compliance across development stages, provide strategic QA leadership, manage a team of 5–9 QA professionals, support QA activities for clinical trial materials, oversee external vendor quality, develop quality systems and procedures, and contribute to regulatory submissions. Requirements: BS in Life Sciences, Chemistry, Engineering, or related field; 15+ years in QA within biopharma, including 10+ years in gene therapy development; deep knowledge of GxP regulations (21 CFR Parts 210/211, 600s, 820, ICH, EU annexes); experience managing CDMOs and supporting regulatory filings. Preferred: advanced degree (MS, PhD, PharmD), certifications (e.g., ASQ CQA, CQE), experience with analytical method validation, process development, and global development organizations. HighValue: gene therapy, clinical development (to Phase 3), GMP compliance, vendor management, regulatory submissions, hybrid work setup based in San Diego, with 30% international/domestic travel.