Senior Director, Radiopharma Quality & Regulatory

Cardinal Health, Inc.; Aurora (CO); On-site; USD 118,000 - 200,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

Health savings account (HSA)

Job summary

Cardinal Health in Aurora, CO seeks a Director of QRA Management to lead quality activities for radiopharmaceutical manufacturing and testing. You will oversee CMOs, FDA inspections, quality systems, and regulatory compliance, guiding the quality team and driving cross-functional collaboration.

Reporting to the Vice President of Quality Management, you will ensure training, qualifications, and nuclear quality standards are met across the site and development programs, with a focus on risk

Qualifications

• Leadership experience building high-performing quality teams in regulated environments.
• Experience managing quality activities for radiopharmaceutical manufacturing and testing.
• Familiarity with cGMP and 21 CFR Parts 210/211 and regulatory inspections.

Responsibilities

• Lead Quality Management for production facility and radiopharmaceutical operations.
• Oversee CMOs, FDA inspections, and regulatory commitments.
• Review and approve batch records, deviations, investigations, and change controls.
• Host FDA inspections and coordinate regulatory responses.
• Grow and develop the quality team and ensure training and qualifications.

Skills

Leadership experience

Cross-functional collaboration

Stakeholder management

Regulatory compliance

People leadership

Education

Bachelor's or advanced degree in related field

Job description

Cardinal Health in Aurora, CO seeks a Director of QRA Management to lead quality activities for radiopharmaceutical manufacturing and testing. You will oversee CMOs, FDA inspections, quality systems, and regulatory compliance, guiding the quality team and driving cross-functional collaboration.

Reporting to the Vice President of Quality Management, you will ensure training, qualifications, and nuclear quality standards are met across the site and development programs, with a focus on risk