Senior QA Director, Radiopharma Quality & Compliance

Lilly Group; Indianapolis (IN); On-site; USD 125,000 - 183,000; Full time

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a QA Associate Director/Director to lead a multi‑shift GMP operation producing radioligand compounds. You will manage QA personnel, release activities, and regulatory compliance while collaborating with external partners.

This role supports site quality, regulatory inspections, and process qualification efforts. The ideal candidate has a Bachelor's in a science/engineering field and at least 5 years of pharmaceutical QA leadership, with strong

Qualifications

• Bachelor's degree in a science, engineering, pharma-related field or equivalent experience.
• 5+ years in pharmaceutical leadership with QA experience, cross-functional collaboration.
• Experience with Radioligand Therapy (RLT) highly preferred.

Responsibilities

• Establish QA roles/responsibilities and ensure QA has accept/reject authority.
• Lead governance to ensure inter‑function alignment and escalation.
• Oversee Quality Management System design, execution, and review aligned with global standards.
• Manage deviation events, root-cause investigations, and corrective actions.
• Support Site Leadership in defining objectives, improvements, and solutions.
• Partner with Technical Services for manufacturing process qualification/re‑qualification.
• Maintain safe work environment and support site safety goals.
• Foster a quality culture with open communication and teamwork.
• Supervise QA staff, coaching, performance management, and fair environment.
• Apply GMP and aseptic radioligand knowledge to site quality and business goals.
• Make decisions within regulatory guidelines for release, deviation, and inspections.
• Influence regulators and internal/external customers to drive site impact.
• Identify and solve quality challenges affecting release and compliance.
• Oversee record review, micro/QC labs, and inspection readiness.
• Contribute to site budgets and resource planning for quality objectives.

Skills

Quality Assurance leadership

Cross-functional collaboration

Regulatory knowledge

Radiopharmaceutical manufacturing

GMP compliance

Project management

Education

Bachelor's degree in science/engineering/pharmaceutical field

Tools

Kneat

Veeva Vault

SAP

Microsoft Office

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks a QA Associate Director/Director to lead a multi‑shift GMP operation producing radioligand compounds. You will manage QA personnel, release activities, and regulatory compliance while collaborating with external partners.

This role supports site quality, regulatory inspections, and process qualification efforts. The ideal candidate has a Bachelor's in a science/engineering field and at least 5 years of pharmaceutical QA leadership, with strong