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

At CG Oncology, we’re advancing innovative immuno-oncology therapies that give new hope to patients with bladder cancer. As a Senior Specialist, Quality Assurance (Commercial GMP), you’ll be part of a growing team ensuring our commercial and clinical manufacturing partners deliver the highest standards of compliance, reliability, and patient safety. This role is perfect for someone ready to expand from routine QA support into a true leadership path — driving improvement and influencing GMP decisions across a fast-scaling biotech organization.

You’ll lead initiatives that translate quality principles into real-world results — from batch record review and deviation oversight to supplier qualification and technology transfer. You’ll collaborate closely with manufacturing, supply chain, and regulatory affairs to ensure our commercial-ready products consistently meet FDA and international expectations. Success means implementing robust processes that protect patients, streamline release timelines, and elevate operational excellence.

Location: Remote

The Opportunity Includes:

• Meaningful mission: advancing novel immunotherapies that improve lives.
• Hands-on impact: build, shape, and mature GMP systems in a dynamic environment.
• Growth path: position designed for future QA leadership or technical management.
• Collaboration: work cross-functionally with brilliant, mission-driven peers.

Qualifications

• 4 years in GMP QA for biologics, cell/gene therapy, or oncology manufacturing. Experience in tech transfer, supplier qualification, or commercial product readiness a plus.
• A minimum of one (1) year demonstrating management of QA projects including directing and organizing personnel to complete critical timeline objectives.
• Experience with commercial drug manufacturing and manufacturing process validation including tech transfer; familiarity with Federal laws and regulations affecting the pharmaceutical industry.
• Experience managing contract manufacturers with operational QA oversight 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.