Associate Director/Director - Quality Assurance

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

Role

Lead Quality Assurance for GMP radioligand manufacturing, overseeing multi-shift operations producing both commercial and late-stage investigational radiopharmaceuticals.

Responsibilities

• establish QA roles and governance
• ensure compliance of Quality Management System with global standards
• lead deviation investigations
• support process validation
• maintain inspection readiness
• manage QA personnel
• oversee record review and release
• microbiology labs
• collaborate with external manufacturing partners
• lead site safety
• foster quality culture
• support continuous improvement initiatives

Requirements

• Bachelor's in a science or engineering field
• 5+ years in pharmaceutical QA, with radiopharmaceutical experience preferred

Skills

• strong knowledge of GMP, radiopharmaceutical manufacturing, quality systems (CFRs, ISO), and inspection management

Preferred

• experience with radioligand therapy
• facility startup
• proficiency in industry systems like Veeva Vault, SAP, Kneat

Qualifications

regulatory compliance expertise, leadership, problem-solving, and communication skills.

WorkSetup

onsite in Indianapolis, with travel as required; reports to the Executive Director, Site Quality Lead.