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Senior GMP Quality Assurance Leader

Job in Durham, Durham County, North Carolina, 27703, USA
Listing for: Duke Clinical Research Institute
Full Time position
Listed on 2026-08-22
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 109856 - 191062 USD Yearly USD 109856.00 191062.00 YEAR
Job Description & How to Apply Below

Duke University’s Office of Regulatory Affairs and Quality (ORAQ) seeks an Associate Director, Quality Assurance to provide strategic leadership for GMP quality programs supporting development and manufacture of therapies and devices. This role partners with investigators, GMP leadership, regulatory stakeholders, and sponsors to ensure quality systems support clinical and manufacturing programs.

Responsibilities include leading QA across multiple facilities, guiding deviations and CAPAs,

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Position Requirements
10+ Years work experience
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