Manager, Commercial Quality Assurance

CG Oncology

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.

Posted 5/9/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $123,000 - $145,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

QA programscGMP complianceQA reviewmanufacturing recordsvalidation recordsbatch recordsauditingchange controldeviationsCAPAs

Soft Skills

managementorganizationleadershipcommunication

Certifications

BS/BA in a relevant scientific discipline