We are dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit.
Senior Director, Clinical Quality Assurance
Location
California
Posted
18 days ago
Salary
$220K - $270K / year
Job Description
Job Requirements
- BS or BA in a scientific discipline required.
- 12+ years of US/EU Clinical QA experience in biologics or pharmaceuticals.
- 5+ years of leadership/supervisory experience.
- Experience in cell therapy and autoimmune programs preferred.
- Commercialization experience a plus.
- Extensive experience with regulatory inspections, vendor qualifications, vendor audits, and internal audits.
- Expert knowledge of global GCP/GVP regulations including: CLIA, CLIP, CAP 21 CFR Parts 11, 50, 54, 56, 312, 320, 812 ICH E6(R2/R3), ICH E8 EU CTR 536/2014, GDPR Annex 11, Annex 13, ATMP Regulation 1394/2007
- Deep understanding of QA expectations for cell therapy clinical trials.
- High proficiency in Microsoft Word, Project, Visio, Excel, and Smartsheet.
Benefits
- Comprehensive benefits, including: Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
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