Ready to make a change and be part of an exciting journey with a clinical stage biotechnology company focused on developing the next evolution of oncolytic immunotherapy for patients with advanced cancer? At CG Oncology, we aim to take the next evolutionary step in delivering innovative cancer care to millions of patients in need worldwide. Together, we are growing rapidly and looking to build a solid foundation of exceptional individuals who share our passion.

Essential Functions of the Job

• The Senior QA Specialist supports QA management personnel in the execution and maintenance of the company’s GxP Quality Systems.
• The Quality Assurance Specialist II conducts audits/reviews of GxP documentation generated internally or externally provided by contract/service organizations which includes but is not limited to manufacturing, CROs, Investigator Sites, etc.

Qualifications

• BS/BA in a relevant scientific discipline; experience may substitute for minimum educational requirements.
• Minimum three (3) years of related experience in Quality Systems and Quality Assurance processes, development, and documentation.
• Minimum one (1) year of related experience at a specialist level.
• Ability to travel for site visits and meetings (estimate <10%).

Total Rewards Include:

• Competitive Salaries
• Annual Performance/Merit Reviews & Performance Bonuses
• Equity
• 401(k) Retirement Plan with 4% Safe Harbor match
• A variety of Health, Dental & Vision plans (HMO, PPO & HDHP) – Anthem/MetLife
• Health and Flexible Savings Accounts – HSA, FSA, FSA-DC
• Critical Illness & Accident Insurance Plans, STD & LTD Coverage Plans
• Generous Paid Time-Off plus Ten (10) Holidays/Year
• Hyatt Legal and Pet Insurance Plans

CG Oncology is an equal opportunity employer and employment decisions are made without regard to sex, race, age, disability, religion, national origin, color, or any other protected class.

No recruiter / agency solicitation please!