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Principal Specialist, Quality Operations
Job in
Morrisville, Wake County, North Carolina, 27560, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
Role
Senior quality assurance professional providing technical leadership within GxP operations, supporting manufacturing, quality control, and quality systems.
Responsibilities- lead complex investigations
- review quality documentation
- assess risks
- and drive continuous improvement initiatives
- serve as a subject matter expert on quality strategies and compliance
- represent Quality during audits and inspections
- contribute to quality system enhancements and operational risk mitigation
- B.S. in science, engineering, or technical field
- 12+ years in cGMP pharma or combination product manufacturing (Master’s preferred)
- strong technical writing, investigation, and change control experience
- demonstrated cross-functional influence and technical mentorship
- ability to work independently in a fast-paced environment
- familiarity with combination products and device regulations
- experience with regulatory inspections
- quality metrics development
- certifications such as ASQ CQE or Lean Six Sigma Black Belt
- extensive GxP experience
- combination product knowledge
- regulatory inspection support
- quality system development
- cross-functional collaboration
not specified; occasional travel likely.
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