Senior Director, Quality Control

Role: Senior Director of Quality Control at CG Oncology, overseeing product quality and QC operations throughout bladder cancer therapies' lifecycle, from clinical to commercial stages. Responsibilities: develop and execute comprehensive quality strategies aligned with regulatory standards, lead QC oversight of manufacturing, analytical validation, product release, and stability; ensure compliance with GxP, facilitate risk management, continuous improvement initiatives, and cross-functional collaboration with Regulatory, Technical Operations, and leadership teams. Qualifications: Bachelor's or Master's in Life Sciences; 10+ years in biopharmaceutical quality roles with 5+ in senior leadership; extensive experience in biologics manufacturing, late-stage development, GxP systems, and regulatory interactions; proven track record in managing quality systems (CAPA, deviations, change control) and product release activities. Preferred: experience with startup biotech environments, global inspections, and strategic quality planning. High-value: focus on biologics for bladder cancer, phase-appropriate quality systems, regulatory submissions (INDs, BLAs), and cross-functional leadership. Work setup: Fully remote with up to 20% domestic/international travel.