Senior Quality Operations Leader, GxP & Compliance

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

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