Senior Specialist, Quality Assurance – Drug Product - Remote

4w1 month ago

CG Oncology, Inc.

US · Full-time · $115,000 – $130,000

About this role

The Senior Specialist, Quality Assurance – Drug Product executes quality assurance activities supporting clinical and commercial manufacturing operations in compliance with cGMP standards. This role focuses on batch record review, vendor oversight, and ensuring accuracy of GMP documentation across internal and external manufacturing.

The individual works closely with contract manufacturers to support tech transfer, process validation, and routine GMP operations. Daily tasks include QA review of batch records, validation protocols, and analytical documentation to ensure compliance and timely batch disposition. They also participate in GMP audits and maintain inspection readiness for internal and external stakeholders.

This position serves as a key contributor within the QA team, supporting inspection readiness and continuous improvement of the GMP Quality System. The role also provides occasional support for clinical labeling and drug substance contract manufacturing as needed. Collaboration with cross-functional teams is essential to ensure compliance and operational excellence.

At CG Oncology, you join a patient-centered team focused on attacking bladder cancer with novel immunotherapies. The company is growing rapidly, offering opportunities to contribute to significant advancements across multiple pipelines. Success in this role requires strong attention to detail and effective cross-functional collaboration.

Requirements

Experience in quality assurance within a cGMP-regulated pharmaceutical or biotech environment.
Knowledge of FDA, ICH, and other relevant regulatory requirements for drug product manufacturing.
Proven ability to perform batch record review and support GMP batch disposition.
Experience with vendor oversight and contract manufacturing quality activities.
Strong attention to detail and ability to manage multiple priorities effectively.
Proficiency in quality systems such as deviations, CAPA, change control, and audit management.

Responsibilities

Support the implementation, revision, and maintenance of QA programs, policies, and procedures to ensure cGMP, FDA, and ICH compliance.
Assist in updating SOPs to mitigate compliance gaps and support commercial QA readiness.
Support QA activities related to drug product tech transfer and process validation, ensuring compliance of validation protocols and reports.
Perform QA review of batch records, validation, and analytical documentation to ensure accuracy and completeness for GMP batch disposition.
Serve as QA point of contact for contract manufacturers, providing oversight of manufacturing, validation, change management, and deviation processes.
Support and participate in GMP audits for vendor qualification or requalification, including preparation and documentation of findings.
Perform QA review of analytical documents related to release testing, stability studies, and method validation.

Benefits

Remote work flexibility
Opportunity to work on novel immunotherapies for bladder cancer
Be part of a rapidly growing company with significant advancements across multiple pipelines