Sr Specialist, QA GCP Compliance

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 Senior Specialist, QA-GCP will play a crucial role in supporting Good Clinical Practice (GCP), quality oversight and compliance program. They will be responsible for maintenance and oversight of internal clinical electronic systems (TMF, Training, CTMS, IRT) including electronic system validation and change control activities as related to computerized systems for 21 CFR Part 11 compliance. In addition to quality assurance responsibilities, the role will provide strategic guidance, mentoring, and leadership within QA initiatives to uphold the integrity of clinical trials, electronic data systems, and regulatory adherence

Location: Remote

Essential Functions

• Lead quality assurance activities for clinical trials and electronic systems, ensuring robust adherence to GxP regulations.
• Provide strategic input to cross-functional teams regarding quality and compliance issues, fostering a culture of excellence in GxP adherence.
• Serve as the QA SME to drive the development, implementation, and continuous improvement of electronic systems and change control processes, including but not limited to electronic data capture (EDC) systems, trial master file(s) (eTMFs), interactive response technology (IRT), and clinical trial management systems (CTMS) systems.
• Perform risk assessments and develop mitigation plans for clinical quality and electronic systems, integrating best practices and regulatory updates.
• Review and provide QA risk assessment and feedback for clinical trial documentation for accuracy and compliance.
• Design and deliver advanced training programs on GxP compliance, quality standards, and system optimization to personnel.
• Stay at the forefront of industry advancements, regulatory changes, and emerging technologies to advise organizational strategy.

Qualifications

• Bachelor’s degree in life sciences, or a related field
• 5-8 years of experience in quality assurance with significant exposure to clinical trials and electronic systems.
• Experience with implementation and management of electronic quality management systems, experience with Veeva system(s) is highly desired
• Strong knowledge of 21 CFR Part 11regulations, GAMP-5, ICH guidelines, US FDA regulations, and GCP applicable to clinical research.
• Experience with internal/external audits, health authority inspections and inspection readiness activities preferred

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