Senior Manager, QA - Commercial GMP

The Senior Manager, QA – Commercial GMP at CG Oncology is responsible for leading Quality Assurance oversight for drug product operations, ensuring GMP compliance, and supporting product lifecycle management in a remote setting.

Location: Remote

Salary: $165k–$185k

Responsibilities

• Provide day-to-day Quality Assurance support for commercial and clinical drug product manufacturing activities, including review and approval of batch records, deviations, investigations, change controls, and CAPAs.
• Serve as the primary QA liaison for contract manufacturing organizations, overseeing quality agreements, performance monitoring, issue resolution, and continuous improvement activities.
• Support drug product lifecycle activities, including technical transfers, process changes, validation activities, and stability programs.
• Lead or support internal and external audits and inspections related to drug product operations.
• Contribute to the continuous improvement of the Quality Management System by identifying trends, recurring issues, and opportunities to strengthen processes, training, and documentation.
• Provide mentorship, guidance, and informal leadership to QA colleagues and cross-functional partners.

Requirements

• BS/BA in a relevant scientific discipline
• At least ten (10) years of experience in Quality Systems and Quality Assurance processes, including development and documentation.
• Minimum of two (2) years in a managerial role, including supervisory experience of QA personnel
• Experience with commercial and clinical drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry.
• Comprehensive knowledge of GMP regulations, ICH, and FDA guidelines critical to sterile product manufacture of biologics.
• Conduct investigations, risk assessments, complete GMP QA related forms, etc.
• Five (5) years of experience in Quality Systems and Drug Product Quality Assurance, particularly in the biotech or pharmaceutical industry.
• Experience with Drug Product Process Performance Qualification leading towards commercialization.
• Experience with analytical method qualification/validation.
• Experience as a QA Manager, including supervisory 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 2025 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

Additional Information

• 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.