Home › Companies › CG Oncology, Inc. › Senior Specialist, Quality Assurance – Drug Substance
Senior Specialist, Quality Assurance – Drug Substance
CG Oncology, Inc. · Remote (United States), United States · Remote · Active · $115,000–$135,000 / year · Rippling ATS
Job facts
| Field | Value |
|---|---|
| Company | CG Oncology, Inc. |
| Title | Senior Specialist, Quality Assurance – Drug Substance |
| Normalized title | - |
| Department / team | Quality Ops |
| Location | United States |
| Work model | Remote / Remote |
| Employment type | Full Time |
| Salary | $115,000–$135,000 / year |
| Status | active |
| ATS provider | Rippling ATS |
| Posted / first seen | 2026-05-19 / 2026-05-29 |
| Changed / last seen | 2026-06-06 / 2026-06-06 |
Related slices
| Page | What it contains | Open |
|---|---|---|
| Company jobs | Active postings from CG Oncology, Inc.. | Open |
| Company breakdowns | Role, location, ATS, and work model facets for this company. | Open |
| ATS provider jobs | Active postings observed through Rippling ATS. | Open |
| Provider filtered search | The same provider as a filtered job collection. | Open |
| Department jobs | Active postings in Quality Ops. | Open |
| Work model jobs | Active Remote postings. | Open |
| Lifecycle events | Open, update, close, and reopen events for this posting. | Open |
| Original posting | Canonical source or apply URL captured from the ATS. | Open |
Linked records
| Company | CG Oncology, Inc. |
| Source | 450a8a94-2c0b-486c-85ea-0b4fe13e58d3 |
| ATS provider | Rippling ATS |
Description
company
About CG Oncology, Inc.
A re 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.
role
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.
Full job record
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| Org ID | 6a707b83-74d8-49ac-a126-cdb325d5a4c2 |
| Source ID | 450a8a94-2c0b-486c-85ea-0b4fe13e58d3 |
| Board ID | 450a8a94-2c0b-486c-85ea-0b4fe13e58d3 |
| Provider | rippling |
| Provider Job Key | c8bc330d-4dbe-4339-908c-488c41f6e1ef |
| Title | Senior Specialist, Quality Assurance – Drug Substance |
| Normalized Title | — |
| Status | active |
| Active | yes |
| Location Text | Remote (United States), United States |
| Department | Quality Ops |
| Team | — |
| Employment Type | full_time |
| Workplace Type | remote |
| Remote Policy | remote |
| Country | United States |
| Region | — |
| City | — |
| Salary Raw | USD 115000-135000 YEAR |
| Salary Min | 115,000 |
| Salary Max | 135,000 |
| Salary Currency | USD |
| Salary Period | year |
| Source URL | https://ats.rippling.com/cgoncologycareers/jobs/c8bc330d-4dbe-4339-908c-488c41f6e1ef |
| Apply URL | https://ats.rippling.com/cgoncologycareers/jobs/c8bc330d-4dbe-4339-908c-488c41f6e1ef |
| First Seen At | 2026-05-29 07:15:00Z |
| Last Seen At | 2026-06-06 20:03:50Z |
| Last Checked At | 2026-06-06 20:03:50Z |
| Last Changed At | 2026-06-06 20:03:50Z |
| Inactive At | — |
| Source Posted At | 2026-05-19 16:41:02Z |
| Source Updated At | — |
| Raw Payload Uri | s3://job-postings-prod-raw-590183727216/raw/provider=rippling/board=cgoncologycareers/date=2026-06-06/2026-06-06T20-03-48-823Z-b022f0d21a45db6118a01e60df611ae8e12ec7f94250d35d9a8597650836e5be.json |
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"role": "<meta><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:15pt;white-space:pre-wrap;\">About the role</strong></b></p><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><span style=\"white-space:pre-wrap;\">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. 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Assist in updating SOPs to mitigate compliance gaps and support commercial QA readiness.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">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.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">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.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">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.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">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.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">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.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">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.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">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.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Additional Responsibilities: Perform other QA-related duties as assigned to support the Commercial Quality Assurance organization.</span></li></ul><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;\"><b><strong style=\"font-size:15pt;white-space:pre-wrap;\">Qualifications</strong></b></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Bachelor’s degree (BS/BA) in a relevant scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, or related field).</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Minimum of four to six (4–6) years of experience in Quality Assurance and/or Quality Systems within the biotechnology or pharmaceutical industry.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Direct experience supporting GMP-regulated drug substance/API manufacturing, including batch record review, process validation support, and documentation compliance.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Experience supporting contract manufacturing organizations (CMOs) or external vendors in a QA capacity.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Hands-on experience with quality systems such as deviations, CAPAs, change control, and/or OOS investigations.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Working knowledge of cGMP regulations, FDA guidelines, ICH standards, and industry best practices related to drug substance/API manufacturing and process validation.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">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.</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Proficiency with electronic quality systems and document management platforms. </span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">Ability to travel domestically and internationally (~20%) as needed.</span></li></ul><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;\"><u><i><b><strong style=\"text-decoration:underline;font-style:italic;white-space:pre-wrap;\">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.</strong></b></i></u></p><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;\"><br></p><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;\"><b><strong style=\"font-size:15pt;white-space:pre-wrap;\">Total Rewards</strong></b></p><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;\"><span style=\"white-space:pre-wrap;\">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.</span></p><ul data-pattern=\"discCircleSquare\" data-depth=\"1\" style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11pt;font-weight:400;margin:8px 0px;line-height:1.6;padding:0px 0px 0px 32px;list-style-type:disc;\"><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">HIGHLY COMPETITIVE SALARIES </span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">ANNUAL PERFORMANCE/MERIT REVIEWS</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">ANNUAL PERFORMANCE BONUSES</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">EQUITY</span></li><li style=\"font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;\"><span style=\"white-space:pre-wrap;\">SPECIAL RECOGNITION</span></li></ul><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;\"><b><strong style=\"font-size:15pt;white-space:pre-wrap;\">Well-Being Benefits</strong></b></p><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;\"><span style=\"white-space:pre-wrap;\">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.</span></p><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;\"><span style=\"white-space:pre-wrap;\">Well-Being Benefits eligibility begins the 1st of the month after hire. 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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.</span></p><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;\"><span style=\"white-space:pre-wrap;\"> </span></p><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;\"><br></p><p style=\"font-family:"Basel Grotesk",Arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px 0px;padding:0px;text-align:start;\"><br></p>",
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