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Global QMS Senior Specialist — Audit & Compliance; Remote

Remote / Online - Candidates ideally in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listing for: United States Digital Space LLC
Remote/Work from Home position
Listed on 2026-08-29
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 90000 - 120000 USD Yearly USD 90000.00 120000.00 YEAR
Job Description & How to Apply Below
Position: Global QMS Senior Specialist — Audit & Compliance (Remote)
Location: Indianapolis

Orca Bios seeks a Senior Specialist, Global QMS to drive the worldwide quality management framework across sites, leading internal audits, supplier management, and inspection readiness for FDA/EMA aligned programs. You will partner with IT and site leadership to ensure compliant, data-driven QMS enhancements and cross-functional governance.

You will establish and monitor KPIs, support QMR processes, and ensure readiness for regulatory inspections while guiding teams to continuously improve

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Position Requirements
10+ Years work experience
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