Senior Director, Quality Control & External QC Ops

Scorpion Therapeutics; Chicago (IL); On-site; USD 180,000 - 260,000; Full time

Job summary

Scorpion Therapeutics in Chicago is seeking a Senior Director of Quality Control to oversee outsourced GxP testing for clinical and commercial products in a contract manufacturing environment. Based at the Chicago HQ, you will lead external QC systems and ensure seamless collaboration with QA and regulatory teams.

This role requires 18+ years in pharma QA/QC, including 12+ years supporting GxP products; a Bachelor's in a related field; and deep expertise in investigations, CAPAs, and regulatory

Qualifications

• Requires a Bachelor's in biotech, chemistry, or related field.
• 18+ years in pharma QA/QC with 12+ years in GxP clinical/commercial.
• Strong knowledge of quality systems, investigations, CAPAs, and regulatory interactions.

Responsibilities

• Establish and manage external QC systems.
• Vendor selection and performance management.
• Lead release and stability testing frameworks.
• Oversee investigations for OOS/OOT.
• Manage reference standards and reagent programs.
• Oversee raw material testing.
• Validate and transfer analytical methods.
• Manage specifications and material qualification.
• Partner QC with QA and ensure inspection readiness.
• Maintain regulatory compliance.
• Prepare for inspections.
• Lead cross-functional collaboration with manufacturing, R&D, regulatory, and legal teams.

Skills

Quality systems

GxP compliance

CAPA investigations

Regulatory interactions

Education

Bachelor’s degree in biotechnology, chemistry, or related field

Advanced technical degree (preferred)

Job description

Scorpion Therapeutics in Chicago is seeking a Senior Director of Quality Control to oversee outsourced GxP testing for clinical and commercial products in a contract manufacturing environment. Based at the Chicago HQ, you will lead external QC systems and ensure seamless collaboration with QA and regulatory teams.

This role requires 18+ years in pharma QA/QC, including 12+ years supporting GxP products; a Bachelor's in a related field; and deep expertise in investigations, CAPAs, and regulatory