Senior Director, Quality Control

Role: Senior Director, Quality Control at CG Oncology, responsible for strategic oversight of quality systems across the lifecycle of bladder cancer therapies from clinical development to commercialization. Responsibilities include establishing global quality strategies, ensuring regulatory compliance, overseeing analytical quality, product release, and validation activities, and driving continuous improvement initiatives. The role entails leading cross-functional collaborations with Regulatory, Technical Operations, and executive teams, managing quality assurance during manufacturing, and representing the company in inspections. Qualifications: Bachelor's or Master's in Life Sciences, with 10+ years in biopharmaceutical quality roles, including 5+ years in senior leadership; extensive GxP, biologics manufacturing, and late-stage development experience; regulatory submission experience; strong leadership and matrixed-team skills. High-value specifics: Focus on biologics and immunotherapies for bladder cancer, with involvement across clinical and commercial stages; deep engagement with regulatory processes, quality systems, and process validation in a GxP environment. Work setup: Fully remote with up to 20% travel; leadership in a fast-growing biotech setting.