Quality Assurance Specialist, GCP

About CG Oncology, Inc.

Are 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.

About the role

The Quality Assurance Specialist – GCP will play a crucial role in supporting Good Clinical Practice (GCP) and Quality Systems compliance. They will be responsible for internal Quality System maintenance, including change control activities related to computerized systems for 21 CFR Part 11 compliance. In addition to Quality Assurance responsibilities, they will provide support to a variety of QA initiatives to uphold the integrity of clinical trials, electronic systems, and regulatory adherence.

Location: Remote

Essential Functions

GCP Compliance & Oversight

• Conduct internal audits and vendor audits to ensure GCP compliance across clinical trials and related activities.
• Review clinical documentation (e.g., protocols, investigator brochures, informed consent forms) for regulatory alignment.
• Support inspection readiness activities and provide compliance guidance to project teams, as needed.
• Collaborate with Clinical Operations and Regulatory Affairs to ensure quality standards are upheld throughout the trial lifecycle.
• Monitor CAPAs related to clinical quality issues and ensure timely resolution.

Quality Management System (QMS) Support

• Assist in the development, implementation, and maintenance of QMS system, policies, procedures, and work instructions.
• Perform gap analyses and contribute to QMS improvement initiatives based on business needs.
• Track and report quality metrics to leadership for continuous improvement.
• Facilitate training sessions on QMS and GCP-related topics for cross-functional teams.

Qualifications

Minimum Education: Bachelor’s degree in life sciences or a related field.

Minimum Experience:

• Three (3) years of experience in quality assurance with significant exposure to clinical trials and electronic systems.
• Experience with the implementation and management of electronic quality management systems, experience with Veeva system(s) is highly desired.
• Experience with internal/external audits, health authority inspections, and inspection readiness activities preferred.

Other Requirements:

• Exceptional communication, strategic thinking, and leadership skills.
• Advanced knowledge of GxP Compliance and Quality Assurance processes.
• Expertise in risk-based approaches to quality management for clinical and electronic systems.
• Excellent problem-solving skills and attention to detail with the ability to develop and present actionable insights for process improvements and efficiencies.

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 rewa