Manager, Commercial Quality Assurance
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Job Description
Manager, Commercial Quality Assurance at CG Oncology managing quality assurance functions related to commercialization and regulatory compliance. Overseeing QA programs and maintaining compliance with GMP standards in a remote setting.
Responsibilities:
- 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
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