Associate Director/Director - Quality Assurance

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, and maintain inspection readiness. Manage QA personnel, oversee record review and release, microbiology labs, and collaborate with external manufacturing partners. Lead site safety, foster quality culture, and 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, and 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.