Vice President, Analytical Development & Quality Control

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

CG Oncology is seeking a Vice President of Analytical Development and Quality Control (VP, AD & QC) to provide strategic and operational leadership across analytical development, quality control, and related compliance activities supporting late-stage clinical development, BLA submission, and commercial readiness. This role is critical to ensuring robust, phase-appropriate analytical strategies, compliant QC operations, and seamless cross-functional collaboration as CG Oncology advances toward commercial launch. The VP, AD & QC will serve as a key member of the Technical Operations leadership team, partnering closely with CMC, Manufacturing, Regulatory Affairs, Quality Assurance, Clinical Development, and external partners to deliver high-quality, compliant analytical systems that support product lifecycle management.

Location: Remote

Essential Functions

• Serve as a strategic partner with the Tech Ops and CMC leadership to define regulatory strategies.
• Bring hands-on experience to author regulatory submissions within US and Ex-US, coaching and guiding AD/QC staff to author reg submissions.
• Work with Tech ops senior leadership to define, develop and execute CGO’s post commercial pathway.
• Build sustainable and appropriate organization structure to support CGO future growth from late stage company to a commercial and growing company.
• Define and execute the global analytical development strategy across all stages of development, from late-stage clinical through commercial lifecycle management.
• Ensure analytical methods are scientifically sound, phase-appropriate, robust, and aligned with regulatory expectations.
• Oversee method development, qualification, validation, transfer, and lifecycle management for drug substance and drug product.
• Lead and scale Quality Control operations, including in-house and external QC testing activities.
• Ensure QC systems meet GMP requirements and remain inspection-ready.
• Support regulatory submissions and serve as an analytical SME for health authority interactions.
• Build, lead, and mentor a high-performing Analytical Development and Quality Control organization.
• Manage external laboratories, CROs, CDMOs, and testing partners. • Collaborate cross-functionally to support tech transfer and commercialization readiness.
• KPO’s - Representing QC/AD during our interactions with regulatory authorities and leading RI/meetings.
• Heading all the operations related to QC for commercial manufacturing including batch release, stability studies.
• Authoring multiple on-going submissions to Regulatory agencies including INDa, BLA, sBLA, comparability reports
• Identifying current gaps in the QC/AD organization and restructure or building it to address CGO needs while growing staff.
• Establish a collaborative environment within Tech Ops and its internal and external facing organizations including but not limited to QA, DS and DP group, supply chain, clinical ops/Dev and our analytical testing vendors.

Qualifications

• PhD or MS in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or related discipline.
• 15+ years of experience in analytical development and/or quality control in biotech or pharma.
• Experience supporting late-stage clinical programs, BLA submissions, and commercial readiness.
• Deep knowledge of GMP, ICH guidelines, and global regulatory expectations.
• Proven experience leading and scaling analytical and QC organizations

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.