Senior Specialist, Quality Assurance – Drug Substance

About the role The Senior Specialist, Quality Assurance – Drug Substance is responsible for executing quality assurance activities that support clinical and commercial manufacturing of drug substance in compliance with cGMP standards. This role focuses on batch record review, vendor oversight support, and ensuring the accuracy and completeness of GMP documentation across internal and external manufacturing operations. The individual will work closely with contract manufacturers and other drug substance CMOs, to support tech transfer, process validation, and routine GMP operations. Success in this role requires strong attention to detail, the ability to manage multiple priorities, and effective cross-functional collaboration to ensure timely batch disposition and compliance. The position operates as a key contributor within the Commercial QA team, supporting inspection readiness and continuous improvement of quality systems. Location: Remote Essential Functions QA Systems Execution & SOP Support: Support the implementation, revision, and maintenance of QA programs, policies, and procedures to ensure compliance with cGMP, FDA, and ICH requirements. Assist in updating SOPs to mitigate compliance gaps and support commercial QA readiness. Tech Transfer & Process Validation Support: Support QA activities related to drug substance tech transfer, process performance qualification (PPQ), and preparation for process validation activities. Ensure QA compliance of validation protocols, reports, and associated GMP documentation during execution. Batch Record Review & GMP Disposition Support: Perform QA review of batch production records, validation data, deviation investigations, and analytical documentation associated with drug substance manufacturing to ensure accuracy, completeness, and compliance with GMP standards. Support timely disposition activities once all required data is available. Vendor QA Oversight Support: Serve as a QA point of contact for assigned contract manufacturers and partners by supporting QA oversight activities, including participation in manufacturing, validation, and change management processes to ensure GMP compliance. GMP Auditing & Inspection Readiness: Support and participate in GMP audits for vendor qualification or requalification (minimum of two), including preparation, execution support, and documentation of findings. Assist in maintaining inspection readiness for internal and external stakeholders. Documentation & Analytical Review: Perform QA review of manufacturing, validation, and analytical documents related to API/drug substance release testing, stability programs, raw materials, intermediates, and analytical method qualification/validation to ensure compliance with regulatory expectations. Quality Event Management Support: Support the review and resolution of quality system events, including deviations, CAPAs, change controls, and out-of-specification investigations. Ensure proper documentation and timely follow-up to support effective closure. Cross-Functional Collaboration & Continuous Improvement: Collaborate with internal teams and external partners to ensure QA requirements are met across manufacturing and quality processes. Identify and support improvements to QA systems, documentation workflows, and compliance processes. Additional Responsibilities: Perform other QA-related duties as assigned to support the Commercial Quality Assurance organization.

Qualifications

Bachelor’s degree (BS/BA) in a relevant scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, or related field). Minimum of four to six (4–6) years of experience in Quality Assurance and/or Quality Systems within the biotechnology or pharmaceutical industry. Direct experience supporting GMP-regulated drug substance/API manufacturing, including batch record review, process validation support, and documentation compliance. Experience supporting contract manufacturing organizations (CMOs) or external vendors in a QA capacity. Hands-on experience with quality systems such as deviations, CAPAs, change control, and/or OOS investigations. Working knowledge of cGMP regulations, FDA guidelines, ICH standards, and industry best practices related to drug substance/API manufacturing and process validation. Ability to review and interpret technical documentation (batch records, validation protocols/reports, analytical data).

• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.

Proficiency with electronic quality systems and document management platforms. Ability to travel domestically and internationally (~20%) as needed. 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. Apply To This Job