We're on a mission to cure blindness with our transformational platform of advanced therapies.
Clinical Quality Assurance Manager
Location
Kentucky + 11 moreAll locations: Kentucky, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Massachusetts, Pennsylvania, South Carolina, South Dakota, Texas, Washington
Posted
2 days ago
Salary
$133K - $160K / year
Seniority
Lead
Job Description
Job Requirements
- Bachelor’s degree in Biology, Chemistry, or other relevant scientific discipline required.
- Minimum of 8–10 years of experience in the pharmaceutical/biotech industry
- At least 5 years specifically in a GCP Quality Assurance lead role.
- Direct experience with Cell Therapy clinical studies is preferred.
- Proven track record of leading or playing a major role in successful regulatory inspections (FDA/EMA).
- Expert Knowledge: Deep mastery of 21 CFR Parts 11, 50, 54, 56, 312, and ICH E6 (R2/R3).
Benefits
- Full health insurance to employees and their families
- 401(k) matching
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Generous Paid Time Off (PTO)
- Paid parking
- Subsidized commuter passes
- In-office catered lunches
- Team events
- Community projects
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