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Quality Affairs Senior Director – Sterile Injectables

Job in Shirley, Suffolk County, New York, 11967, USA
Listing for: American Regent, Inc.
Full Time position
Listed on 2026-08-06
Job specializations:
  • Quality Assurance - QA/QC
  • Healthcare
    Medical Science
Salary/Wage Range or Industry Benchmark: 150000 - 190000 USD Yearly USD 150000.00 190000.00 YEAR
Job Description & How to Apply Below

American Regent, Inc. is seeking a high-level Quality leader reporting to the Senior Director of Quality, guiding the quality management system for sterile injectable manufacturing.

You will oversee laboratory operations, regulatory inspections, supplier quality, and external CMOs, ensuring cGMP compliance and robust continual improvement. You will drive KPI-based quality programs, manage deviation/ CAPA processes, and collaborate with Production, Regulatory Affairs, Engineering, R&D and QA

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Position Requirements
10+ Years work experience
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