Associate Director, QA — Radiopharmaceuticals (GMP)

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 130,000 - 180,000; Full time

Job summary

Scorpion Therapeutics seeks a Lead Quality Assurance for GMP radioligand manufacturing in Indianapolis. You will oversee multi-shift operations producing commercial and late-stage investigational radiopharmaceuticals, ensuring QA governance and inspection readiness.

The role reports to the Executive Director, Site Quality Lead. Key responsibilities include deviation investigations, process validation support, and fostering a strong quality culture across internal and external manufacturing

Qualifications

• Bachelor's degree in a science or engineering field.
• 5+ years in pharmaceutical QA, with radiopharmaceutical experience preferred.
• Strong regulatory compliance expertise (GMP, CFRs) and leadership capability.

Responsibilities

• Establish QA roles and governance.
• Ensure Quality Management System compliance with global standards.
• Lead deviation investigations.
• Support process validation.
• Maintain inspection readiness.
• Manage QA personnel.
• Oversee record review and release.
• Collaborate with external manufacturing partners.
• Lead site safety.
• Foster quality culture.
• Support continuous improvement initiatives.

Skills

GMP knowledge

Radiopharmaceutical manufacturing

Quality systems

Inspection management

Leadership

Education

Bachelor's in science or engineering

Tools

Veeva Vault

SAP

Kneat

Job description

Scorpion Therapeutics seeks a Lead Quality Assurance for GMP radioligand manufacturing in Indianapolis. You will oversee multi-shift operations producing commercial and late-stage investigational radiopharmaceuticals, ensuring QA governance and inspection readiness.

The role reports to the Executive Director, Site Quality Lead. Key responsibilities include deviation investigations, process validation support, and fostering a strong quality culture across internal and external manufacturing