Manager, Commercial Quality Assurance

About the role

• The Manager, Commercial Quality Assurance will manage quality assurance functions related to commercialization, clinical development, and regulatory compliance of products. This role is responsible for supporting the development, implementation, and maintenance of QA systems and activities, ensuring compliance with GMP standards. The Manager will lead audits, manage quality investigations, and collaborate with internal teams and external partners to resolve product quality issues. The role also includes oversight of documentation related to GMP activities. This role will support the Commercial Quality Assurance organization.

Location: Remote

Essential Functions

• QA Program Development: Support the development, improvement, and management of QA programs, policies, and procedures to ensure cGMP compliance.
• Vendor and Partner Management: Serve as the QA contact for specified vendors, contract facilities, or joint development collaborators. Through QA oversight, project team participation, and QA representation for batch manufacture oversight, validation activities, change management, and other GMP related activities, ensure cGMP requirements are met. Support the process for Sponsor batch disposition.
• Document Review and Management: Perform QA review of manufacturing records, validation related records, batch records, and documents submitted to regulatory agencies.
• GMP Auditing and Inspections: Lead cGMP auditing of vendors. Support inspection readiness programs to ensure that the Sponsor and vendors have successful inspectional outcomes.
• Analytical Document Review: Review analytical documents related to release testing, stability testing, reference standards, and analytical method qualification/validation.
• Issue Resolution: Provide input on the vendor’s Quality System events, including change control, deviations, investigation, out-of-specifications, and CAPAs.
• Other: Perform other related duties as assigned or requested

Qualifications

• BS/BA in a relevant scientific discipline.
• At least five (5) years of experience in Quality Systems and Quality Assurance processes, including development and documentation.
• A minimum of three (3) years demonstrating management of QA projects including directing and organizing personnel to complete critical timeline objectives.
• Experience with commercial drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry.
• Experience of managing contract manufacturers with direct 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 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.