Principal Specialist, Quality Operations

Scorpion Therapeutics; Morrisville (NC); On-site; USD 130,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior quality assurance professional to provide technical leadership within GxP operations, supporting manufacturing, quality control, and quality systems. The role focuses on investigations, documentation review, risk assessment, and continuous improvement across the Quality organization.

The successful candidate will act as a subject matter expert on quality strategies, support regulatory inspections, and help advance quality system development in a

Qualifications

• 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.

Responsibilities

• Lead complex investigations and drive root-ccause analysis.
• Review quality documentation for compliance and accuracy.
• Assess risks and implement mitigation strategies.
• Drive continuous improvement initiatives across Quality and Manufacturing.
• 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.

Job description

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

Requirements

• 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

Preferred Qualifications

• 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

High Value

• extensive GxP experience
• combination product knowledge
• regulatory inspection support
• quality system development
• cross-functional collaboration

Work Setup

not specified; occasional travel likely.