CG Oncology

QA Engineer

• You’ll lead initiatives that translate quality principles into real-world results — from batch record review and deviation oversight to supplier qualification and technology transfer.
• You’ll collaborate closely with manufacturing, supply chain, and regulatory affairs to ensure our commercial-ready products consistently meet FDA and international expectations.
• Success means implementing robust processes that protect patients, streamline release timelines, and elevate operational excellence.

Senior Specialist, Quality Assurance, Commercial GMP

Compliance

• The Sr. Manager, IT (SOX) Compliance & Systems is responsible for leading and managing CG Oncology’s IT General Controls (ITGC) and IT SOX compliance program while also overseeing core system administration functions.
• This role ensures that IT processes, systems, and controls meet regulatory, security, and operational standards required for a publicly traded biopharmaceutical company.
• Manage day-to-day IT operations, including request management, issue resolution, and general system maintenance to ensure optimal performance and user satisfaction.
• Partner closely with Finance, Internal Audit, cross-functional business teams, and vendors to maintain compliance, remediate gaps, and drive continuous improvement in IT risk management, governance, and operational efficiency.
• Oversee issue management processes, including troubleshooting, root cause analysis, and escalation for IT systems and applications.
• Oversee, manage and/or produce all required documentation to meet audits requirements.
• Perform general system administration and maintenance, including user account provisioning, system updates, patching, and performance monitoring.
• Manage IT service requests and incidents, ensuring timely resolution and adherence to SLAs.

Senior Manager, IT Compliance, Systems

• Conduct internal audits and vendor audits to ensure GCP compliance across clinical trials and related activities
• Review clinical documentation (protocols, investigator brochures, informed consent forms) for regulatory alignment
• Support inspection readiness activities and provide compliance guidance to project teams
• Collaborate with Clinical Operations and Regulatory Affairs to ensure quality standards throughout the trial lifecycle
• Monitor CAPAs related to clinical quality issues and ensure timely resolution
• Assist in development, implementation, and maintenance of QMS policies, procedures, and work instructions
• Perform gap analyses and contribute to QMS improvement initiatives
• Track and report quality metrics to leadership for continuous improvement
• Facilitate training sessions on QMS and GCP-related topics for cross-functional teams
• Manage change control activities related to computerized systems for 21 CFR Part 11 compliance

Quality Assurance Specialist, GCP

Financial Planning and Analysis

• This role seeks a highly motivated and experienced Senior FP&A Analyst to join the finance team at CG Oncology.\n• The analyst will be a key contributor to financial planning and analysis processes.\n• They will provide critical insights and analysis to support strategic decision-making and drive financial performance within CG Oncology.\n• Location: Remote\n• Essential Functions: Assist with the development of annual budgets, quarterly forecasts, and long-range financial plans. This includes collaborating with various departments to gather data and ensure alignment with strategic objectives.\n• Develop, maintain, and enhance complex financial models for various business units, projects, and products. This supports forecasting, scenario planning, and financial decision-making.\n• Conduct in-depth financial analysis, including variance analysis against budget and forecast. Identify key performance drivers, risks, and opportunities for improvement.\n• Prepare and present clear, concise financial reports and dashboards for senior management and executive teams. Provide insightful commentary and actionable recommendations.\n• Partner with cross-functional teams, such as R&D, Manufacturing, and SG&A. The goal is to understand business drivers and provide financial insights to support operational and strategic initiatives.\n• Support month-end and year-end close processes. Ensure accuracy and completeness of financial reporting and analysis.\n• Drive continuous process improvements within the FP&A function. Streamline reporting, enhance data reliability, and leverage financial systems and tools to improve efficiency and accuracy.\n• Perform ad-hoc financial analyses and provide recommendations to support various strategic initiatives and special projects as requested by senior leadership.

Senior Specialist, Quality Assurance, Commercial GMP

Senior Manager, IT Compliance, Systems

Quality Assurance Specialist, GCP

Senior Analyst, Financial Planning & Analysis