Associate Director, GxP Electronic Systems Quality Assurance

Role: Lead the Global Quality Systems Monitoring & Excellence program within a late-stage oncology biopharma developing RAS-targeted therapies, ensuring compliance, governance, and continuous improvement of QMS. Responsibilities: oversee audit readiness, inspection support, KPI/KQI analysis, CAPA governance, critical issue management, process standardization, and digital quality initiatives using AI and data analytics; build and lead a high-performing team. Requirements: Bachelor's in Life Sciences, Pharmacy, or related field; 10+ years in QA/QMS roles in biotech/pharma, with regulatory inspection experience; strong knowledge of FDA, EMA, ICH regulations; experience with eQMS (e.g., Veeva Vault); leadership and stakeholder management skills. Preferred: experience supporting late-stage clinical and commercial products; knowledge of digital transformation and analytics; certifications like ASQ CQA or RAC. High-Value: focus on GxP compliance, regulatory inspection readiness, digital quality platforms, and leadership in a fast-paced, regulated environment. Location: onsite Redwood City, CA, with a salary range of $186K-$233K, commensurate with experience.