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. We invite you to review our website to learn more about our company and team by visiting our website at https://www.cgoncology.com/careers/#overview.

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Role: SENIOR QA SPECIALIST

Location: Remote US-Based

Essential Functions:

• The Senior QA Specialist supports QA management personnel in the execution and maintenance of the company’s GxP Quality Systems.
• The Senior QA Specialist 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.
• The Senior QA Specialist participates in the administration of the company’s GxP Quality Systems (not limited to: Document Control System, Training Program, Deviations, and CAPA).
• The Senior QA Specialist manages QA GxP documentation (audit files, raw data, reports, batch records, training records, deviations, CAPA, etc.)

Qualifications:

• BS/BA in a relevant scientific discipline; experience may substitute for minimum educational requirements.
• Experience in drug manufacturing/development field is a requirement.
• 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.
• Experience with Biologics is preferred.
• Ability to travel for site visits and meetings (estimate <10%).

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

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to the meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.

• FULLY REMOTE WORK ENVIRONMENT
• REST & RECHARGE - Unlimited Paid Time Off (PTO)
• HOLIDAYS – We observe 10 Holidays/year
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – HMOs, PPOs & HDHP – Anthem/MetLife
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company Paid 1 x base salary up to $300,000 + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

CG Oncology is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.

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.