Sr. Director, Quality Control

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

Role

Senior Director of Quality Control (QC) overseeing outsourced GxP testing for clinical and commercial products in a contract manufacturing environment.

Responsibilities

• establish and manage external QC systems
• vendor selection and performance
• release and stability testing frameworks
• investigation governance for OOS/OOT
• reference standard and reagent programs
• raw material testing
• analytical method validation and transfer
• specification and material qualification management
• QC partnership with QA
• regulatory compliance
• inspection readiness
• lead cross-functional collaboration with manufacturing, R&D, regulatory, and legal teams.

Requirements

• Bachelor’s degree in biotechnology, chemistry, or related field
• 18+ years’ pharma QA/QC experience, including 12+ years supporting GxP clinical and commercial products
• strong knowledge of quality systems, investigations, CAPAs, and regulatory interactions

Preferred

advanced technical degree.

High Value

expertise in GxP environments for biologics or pharmaceuticals, regulatory submissions (INDs, NDAs, BLAs), stability data management, and external vendor oversight.

Work Setup

based in Chicago HQ, minimum 4 days/week onsite; periodic travel may be required.