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Biologics BLA QA & PAI Readiness Director
Job in
Dayton, Montgomery County, Ohio, 45444, USA
Listed on 2026-08-27
Listing for:
Solvita
Full Time
position Listed on 2026-08-27
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Solvita in Dayton, OH seeks a BLA Quality Assurance Director to lead PAI preparation and execution for biologics across client-sponsored filings and post-approval changes. You will drive cGMP enhancements, oversee multi-site QA programs, coordinate with FDA inquiries, and ensure readiness for Pre-Approval Inspections with cross-functional teams.
The role requires 12+ years in biologics QA, strong leadership, and proven experience guiding PAI and regulatory interactions; travel may be required.
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