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Sr Director, Quality Control
<meta><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">About the role</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;">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.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="color:rgb(0,0,0);background-color:rgb(255,255,255);font-size:15pt;white-space:pre-wrap;"> </strong></b><b><strong style="font-size:15pt;white-space:pre-wrap;">Location: </strong></b><span style="white-space:pre-wrap;">Remote</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><br></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Essential Functions</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Strategic Quality Leadership</span></li><li style="list-style:none;font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:circle;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Establish and drive the global quality strategy aligned with corporate objectives, regulatory expectations, and risk-based approaches to product development and commercialization.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Develop and lead quality strategy across the product lifecycle (clinical to commercial), ensuring operational excellence, phase-appropriate quality systems, and regulatory compliance.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Represent Quality in strategic discussions and business planning across Technical Operations, Regulatory, and the Executive Leadership Team (ELT). </span></li></ul></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Regulatory and Quality Oversight </span></li><li style="list-style:none;font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:circle;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Serve as quality SME for manufacturing campaigns, CMC strategy, and regulatory submissions (e.g., IND, BLA, supplements). </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Lead quality input for QTPP, CQA assessments, control strategies, stability programs, and product specifications.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Direct strategic oversight of assay validation, raw materials qualification, reference standards, comparability assessments, and analytical bridging documentation.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">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. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">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. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">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. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Establish and maintain product quality review processes, including Annual Product Reviews (APR/PQR), trend analysis, complaint trending, and ongoing process verification activities.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Ensure analytical methods, specifications, and product control strategies remain phase appropriate, inspection-ready, and aligned with evolving regulatory expectations. </span></li></ul></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Manufacturing & Process Support</span></li><li style="list-style:none;font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:circle;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Partner with Technical Operations leadership team, AD, and CDMOs to ensure quality-compliant and phase-appropriate manufacturing processes and analytical methods.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Provide guidance for validation activities (e.g., assay/process validation, tech transfers, PPQ) to support launch-readiness and lifecycle management.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Ensure the integrity, reliability, and traceability of quality data reporting to leadership and regulatory bodies.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Partner closely with Analytical Development, Manufacturing Sciences & Technology (MSAT), and CDMOs to ensure assay reliability, testing robustness, and product release readiness.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Oversee implementation and continuous improvement of product quality metrics, including deviation rates, CAPA effectiveness, right-first-time performance, assay variability, and lot acceptance trends. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Provide quality leadership during technology transfer, process characterization, PPQ campaigns, and commercial launch activities with emphasis on product quality consistency and control.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Ensure data integrity, ALCOA+ compliance, and inspection readiness across laboratory systems, analytical data management platforms, and product quality records.</span></li></ul></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Systems, Risk Management, and Continuous Improvement</span></li><li style="list-style:none;font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:circle;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Lead quality risk management initiatives, including root cause investigations, CAPAs, and change control in collaboration with QA. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Establish and improve systems and analytics to support audit readiness, inspection outcomes, and proactive compliance.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Drive operational efficiency and culture of continuous improvement across product quality systems and cross-functional teams. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Lead cross-functional product quality governance forums to proactively identify emerging quality risks, product trends, and compliance gaps across internal and external manufacturing networks.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Drive implementation of advanced quality analytics and risk-based monitoring tools to improve product quality visibility, predictability, and decision-making.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Establish proactive product quality surveillance programs to monitor process capability, assay performance, complaint trends, and stability outcomes throughout the product lifecycle.</span></li></ul></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Leadership and Collaboration</span></li><li style="list-style:none;font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><ul data-pattern="discCircleSquare" data-depth="2" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin-left:0px;margin-right:0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:circle;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Serve as a key Quality leader in cross-functional teams (CMC, Tech Ops, Regulatory) to assess and influence external manufacturing and supply strategies. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Build, mentor, and manage a high-performing quality team aligned with CG Oncology values and performance culture.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Represent Quality during regulatory inspections, executive updates, and industry forums.</span></li></ul></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Qualifications</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Bachelor’s or master’s degree in a life sciences discipline (e.g., Biology, Chemistry, Engineering)</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">10 years in biopharmaceutical Quality roles, including 5+ years in senior leadership</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Extensive experience in GxP, biologics manufacturing, late-stage development, and BLA-enabling activities</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Strong regulatory experience including authoring/reviewing submissions and representing company in global inspections </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Hands-on with product quality systems: CAPA, deviations, change control, batch release, comparability</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Demonstrated success working in matrixed environments</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">High EQ and professional presence</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Up to 20% travel (domestic/international)</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Familiarity with startup biotech operations and the ability to flex between strategic and tactical needs</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><u><i><b><strong style="text-decoration:underline;font-style:italic;white-space:pre-wrap;">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.</strong></b></i></u></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><br></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Total Rewards</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HIGHLY COMPETITIVE SALARIES </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ANNUAL PERFORMANCE/MERIT REVIEWS</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ANNUAL PERFORMANCE BONUSES</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">EQUITY</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">SPECIAL RECOGNITION</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Well-Being Benefits</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">FULLY REMOTE WORK ENVIRONMENT</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HOLIDAYS –In 2026 we will observe 14 holidays</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><b><strong style="white-space:pre-wrap;">CG Oncology is an Equal Opportunity Employer</strong></b><span style="white-space:pre-wrap;">:</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><br></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><br></p>