Software QA Analyst II
SmartLight Analytics
SQL
Senior Specialist, Quality Assurance, Commercial GMP
CG Oncology
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $111,000 - $130,000 per year
Job Level
Senior
About the role
- You’ll lead initiatives that translate quality principles into real-world results — from batch record review and deviation oversight to supplier qualification and technology transfer.
- You’ll collaborate closely with manufacturing, supply chain, and regulatory affairs to ensure our commercial-ready products consistently meet FDA and international expectations.
- Success means implementing robust processes that protect patients, streamline release timelines, and elevate operational excellence.
Requirements
- 4 years in GMP QA for biologics, cell/gene therapy, or oncology manufacturing.
- Experience in tech transfer, supplier qualification, or commercial product readiness a plus.
- A minimum of one (1) year demonstrating management of QA projects including directing and organizing personnel to complete critical timeline objectives.
- Experience with commercial drug manufacturing and manufacturing process validation including tech transfer; familiarity with Federal laws and regulations affecting the pharmaceutical industry.
- Experience managing contract manufacturers with 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 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMP QAtech transfersupplier qualificationcommercial product readinessmanufacturing process validationoperational QA oversightproject managementbatch record reviewdeviation oversightregulatory compliance
Soft skills
leadershipcollaborationorganizational skillscommunicationproblem-solving
