About CG Oncology, Inc.

Are 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 Senior Manager, QA – Commercial GMP is responsible for leading and executing Quality Assurance oversight for commercial-and clinical stage drug product operations, ensuring sustained GMP compliance across internal manufacturing activities and external contract manufacturing organizations. The position serves as the primary QA partner for drug product lifecycle management, including commercial production, technical transfers, change management, deviation management, and inspection readiness. Success in this role requires balancing hands-on QA execution with strategic oversight, cross-functional influence, and regulatory judgment in a fast-moving environment. The individual will work closely with Technical Operations (Manufacturing and Quality Control), Supply Chain, Regulatory Affairs, and external contractors to ensure product quality and patient safety. As part of the Commercial GMP QA leadership team, this role is expected to contribute to continuous improvement initiatives and help scale quality systems to support future growth. Many routine quality monitoring, documentation review, and trend analysis activities are increasingly supported by digital quality systems and AI-enabled analytics, requiring the individual to effectively integrate technology into day-to-day QA decision-making.

Location: Remote

Essential Functions

• Provide day-to-day Quality Assurance support for commercial and clinical drug product manufacturing activities, including review and approval of batch records, deviations, investigations, change controls, and CAPAs, ensuring decisions are scientifically sound and compliant with GMP requirements. Performance will be evaluated based on quality of documentation, timeliness of reviews, and effectiveness of corrective actions.
• Serve as the primary QA liaison for assigned contract manufacturing organizations, overseeing quality agreements, performance monitoring, issue resolution and escalation, and continuous improvement activities. This includes conducting and supporting audits, evaluating quality metrics, and ensuring alignment with internal quality expectations. Success will be measured by successful resolution of issues and timely escalation of critical issues to management.
• Support drug product lifecycle activities, including technical transfers, process changes, validation activities, and stability programs, by providing proactive QA input and risk-based decision-making. Effectiveness will be demonstrated by smooth execution of changes with minimal quality disruptions.
• Lead or support internal and external audits and inspections related to drug product operations, including preparation, execution, response development, and follow-up actions. Performance will be assessed based on inspection outcomes, quality of responses, and timely closure of commitments.
• Contribute to the continuous improvement of the Quality Management System by identifying trends, recurring issues, and opportunities to strengthen processes, training, and documentation. Success will be measured by measurable improvements in quality metrics and inspection readiness indicators.
• Provide mentorship, guidance, and informal leadership to QA colleagues and cross-functional partners, helping to build a strong quality culture across commercial operations. Effectiveness will be reflected in stakeholder feedback, team capability development, and consistent application of quality standards.

Qualifications

• BS/BA in a relevant scientific discipline
• At least ten (10) years of experience in Quality Systems and Quality Assurance processes, including development and documentation.
• Minimum of two (2) years in a managerial role, including supervisory experience of QA personnel
• Experience with commercial and clinical drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry.
• Comprehensive knowledge of GMP regulations, ICH, and FDA guidelines critical to sterile product manufacture of biologics.
• Conduct investigations, risk assessments, complete GMP QA related forms, etc.
• Five (5) years of experience in Quality Systems and Drug Product Quality Assurance, particularly in the biotech or pharmaceutical industry.
• Experience with Drug Product Process Performance Qualification leading towards commercialization.
• Experience with analytical method qualification/validation.
• Experience as a QA Manager, including supervisory responsibilities

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 2025 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.