Manager, Commercial Quality Assurance

🕒 May 9

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CG Oncology

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2010

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $120M Series E on 2022-11

Biotechnology • Healthcare Insurance • Pharmaceuticals

CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing innovative oncolytic immunotherapies for patients with bladder cancer. The company's primary investigational product, cretostimogene grenadenorepvec, aims to provide a bladder-sparing therapeutic option, enhancing the quality of life for afflicted patients. With ongoing clinical studies highlighting the potential benefits of their therapies, CG Oncology strives to address the unmet needs in bladder cancer treatment.

📋 Description

• Support the development, improvement, and management of QA programs, policies, and procedures to ensure cGMP compliance. • Serve as the QA contact for specified vendors, contract facilities, or joint development collaborators. • Perform QA review of manufacturing records, validation related records, batch records, and documents submitted to regulatory agencies. • Lead cGMP auditing of vendors. • Provide input on the vendor’s Quality System events, including change control, deviations, investigation, out-of-specifications, and CAPAs.

🎯 Requirements

• BS/BA in a relevant scientific discipline. • At least five (5) years of experience in Quality Systems and Quality Assurance processes, including development and documentation. • A minimum of three (3) years demonstrating management of QA projects including directing and organizing personnel to complete critical timeline objectives. • Experience with commercial drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry. • Experience of managing contract manufacturers with direct operational QA oversight responsibilities

🏖️ Benefits

• HIGHLY COMPETITIVE SALARIES • ANNUAL PERFORMANCE/MERIT REVIEWS • ANNUAL PERFORMANCE BONUSES • EQUITY • SPECIAL RECOGNITION • FULLY REMOTE WORK ENVIRONMENT • REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off • HOLIDAYS – In 2026 we will observe 14 holidays • RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary • HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal • 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 + Voluntary Plans • ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More