Sr Director, Quality Control

About CG Oncology, Inc. A re you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world. Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you. About the role The Sr Director, Quality Control at CG Oncology reports to the VP, Analytical Development and Quality Control and serves as a strategic leader responsible for end-to-end product quality and quality control oversight across the product lifecycle—from clinical development through commercial launch and building commercial Quality Control capabilities—of CG Oncology’s bladder cancer therapies. This role ensures product quality, regulatory alignment, and operational excellence through robust quality systems, analytical quality oversight, product release governance, strategic quality planning, and cross-functional coordination. The Sr Director, Quality Control will help shape the quality vision and execution plan in alignment with CG Oncology’s mission and compliance standards, while partnering closely with Technical Operations, Regulatory Affairs, and executive leadership. Location: Remote Essential Functions Strategic Quality Leadership Establish and drive the global quality strategy aligned with corporate objectives, regulatory expectations, and risk-based approaches to product development and commercialization. Develop and lead quality strategy across the product lifecycle (clinical to commercial), ensuring operational excellence, phase-appropriate quality systems, and regulatory compliance. Represent Quality in strategic discussions and business planning across Technical Operations, Regulatory, and the Executive Leadership Team (ELT). Regulatory and Quality Oversight Serve as quality SME for manufacturing campaigns, CMC strategy, and regulatory submissions (e.g., IND, BLA, supplements). Lead quality input for QTPP, CQA assessments, control strategies, stability programs, and product specifications. Direct strategic oversight of assay validation, raw materials qualification, reference standards, comparability assessments, and analytical bridging documentation. Provide strategic oversight of product release activities, including batch record review, lot disposition support, deviation escalation, and product impact assessments for clinical and commercial materials. Lead oversight of QC testing programs including in-process, release, stability, environmental monitoring, and raw material testing to ensure compliant and reliable product quality outcomes. Ensure robust governance of Out-of-Specification (OOS), Out-of-Trend (OOT), invalid assay, and laboratory investigation processes, including escalation, root cause analysis, and effectiveness monitoring. Establish and maintain product quality review processes, including Annual Product Reviews (APR/PQR), trend analysis, complaint trending, and ongoing process verification activities. Ensure analytical methods, specifications, and product control strategies remain phase appropriate, inspection-ready, and aligned with evolving regulatory expectations. Manufacturing & Process Support Partner with Technical Operations leadership team, AD, and CDMOs to ensure quality-compliant and phase-appropriate manufacturing processes and analytical methods. Provide guidance for validation activities (e.g., assay/process validation, tech transfers, PPQ) to support launch-readiness and lifecycle management. Ensure the integrity, reliability, and traceability of quality data reporting to leadership and regulatory bodies. Partner closely with Analytical Development, Manufacturing Sciences & Technology (MSAT), and CDMOs to ensure assay reliability, testing robustness, and product release readiness. Oversee implementation and continuous improvement of product quality metrics, including deviation rates, CAPA effectiveness, right-first-time performance, assay variability, and lot acceptance trends. Provide quality leadership during technology transfer, process characterization, PPQ campaigns, and commercial launch activities with emphasis on product quality consistency and control. Ensure data integrity, ALCOA+ compliance, and inspection readiness across laboratory systems, analytical data management platforms, and product quality records. Systems, Risk Management, and Continuous Improvement Lead quality risk management initiatives, including root cause investigations, CAPAs, and change control in collaboration with QA. Establish and improve systems and analytics to support audit readiness, inspection outcomes, and proactive compliance. Drive operational efficiency and culture of continuous improvement across product quality systems and cross-functional teams. Lead cross-functional product quality governance forums to proactively identify emerging quality risks, product trends, and compliance gaps across internal and external manufacturing networks. Drive implementation of advanced quality analytics and risk-based monitoring tools to improve product quality visibility, predictability, and decision-making. Establish proactive product quality surveillance programs to monitor process capability, assay performance, complaint trends, and stability outcomes throughout the product lifecycle. Leadership and Collaboration Serve as a key Quality leader in cross-functional teams (CMC, Tech Ops, Regulatory) to assess and influence external manufacturing and supply strategies. Build, mentor, and manage a high-performing quality team aligned with CG Oncology values and performance culture. Represent Quality during regulatory inspections, executive updates, and industry forums. Qualifications Bachelor’s or master’s degree in a life sciences discipline (e.g., Biology, Chemistry, Engineering) 10 years in biopharmaceutical Quality roles, including 5+ years in senior leadership Extensive experience in GxP, biologics manufacturing, late-stage development, and BLA-enabling activities Strong regulatory experience including authoring/reviewing submissions and representing company in global inspections Hands-on with product quality systems: CAPA, deviations, change control, batch release, comparability Demonstrated success working in matrixed environments High EQ and professional presence Up to 20% travel (domestic/international) Familiarity with startup biotech operations and the ability to flex between strategic and tactical needs Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid. Total Rewards CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer. HIGHLY COMPETITIVE SALARIES ANNUAL PERFORMANCE/MERIT REVIEWS ANNUAL PERFORMANCE BONUSES EQUITY SPECIAL RECOGNITION Well-Being Benefits In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work. Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered. FULLY REMOTE WORK ENVIRONMENT REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off HOLIDAYS –In 2026 we will observe 14 holidays RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More CG Oncology is an Equal Opportunity Employer : All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.