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Senior Director, Clinical QA: Inspection Risk

Job in Waltham, Middlesex County, Massachusetts, 02254, USA
Listing for: Alkermes
Full Time position
Listed on 2026-09-01
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 180000 - 240000 USD Yearly USD 180000.00 240000.00 YEAR
Job Description & How to Apply Below
Position: Senior Director, Clinical QA: Inspection-Ready & Risk-Based

Alkermes is seeking a Clinical Quality Assurance Senior Leader to provide strategic leadership and operational oversight of GLP/GCP/GVP quality programs across global clinical trials. This role ensures readiness for inspections, supports NDA/BIMO milestones, and collaborates across departments to advance development programs.

You will build high-performing teams, influence in a matrixed environment, and anticipate evolving regulatory expectations to maintain compliant quality systems.

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Position Requirements
10+ Years work experience
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