Senior Specialist, Quality Assurance – Drug Substance

CG Oncology

10d•$115,000 - $135,000•Remote

About The Position

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.

Requirements

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.

Nice To Haves

Ability to travel domestically and internationally (~20%) as needed.

Responsibilities

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.
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.
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.
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.
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.
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.
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.
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.
Perform other QA-related duties as assigned to support the Commercial Quality Assurance organization.