Senior QA Director - Radiopharma Quality & Compliance

Regulatory Jobs; Indianapolis (IN); On-site; USD 125,000 - 183,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical, dental, vision benefits

Job summary

Lilly, headquartered in Indianapolis, IN, seeks a QA Associate Director/Director to lead a multi-shift GMP operation focused on radioligand products. You will supervise QA staff, ensure release decisions, and maintain regulatory inspections readiness while partnering with manufacturing and quality functions.

The role requires a strong QA background in radiopharmaceuticals, cross-functional leadership, and strategic oversight to support site objectives and lifecycle management.

Qualifications

• Bachelor’s degree in a science, engineering, pharmaceutical field or equivalent.
• 5+ years in pharmaceutical leadership with QA experience, cross-functional work.
• Experience with radiopharmaceuticals and regulatory requirements is preferred.

Responsibilities

• Lead governance and establish QA roles with proper release authority.
• Oversee deviation investigations and root cause analysis per global procedures.
• Support site leadership in defining objectives and improvement plans.
• Collaborate with Technical Services on qualification of manufacturing processes.
• Maintain inspection readiness and regulatory compliance across sites.

Skills

Leadership

Communication

Problem solving

Training & mentoring

Cross-functional collaboration

Organizational skills

Regulatory inspections readiness

Education

Bachelor’s degree in science/engineering/pharma

Tools

Kneat

Veeva Vault

SAP

Manufacturing Execution Systems

Microsoft Office

Job description

Lilly, headquartered in Indianapolis, IN, seeks a QA Associate Director/Director to lead a multi-shift GMP operation focused on radioligand products. You will supervise QA staff, ensure release decisions, and maintain regulatory inspections readiness while partnering with manufacturing and quality functions.

The role requires a strong QA background in radiopharmaceuticals, cross-functional leadership, and strategic oversight to support site objectives and lifecycle management.