Director of Radiopharma Quality & Compliance

HITEC; Aurora (CO); On-site; USD 118,000 - 200,000; Full time

Job summary

Cardinal Health in Aurora, CO seeks a Director of QRA Management to lead all quality activities for radiopharmaceutical manufacturing and testing. This role oversees CMOs, FDA inspections, quality systems, and regulatory compliance, driving cross-functional collaboration across the site.

The successful candidate will manage a diverse team, ensure training and qualifications, and partner with executive leadership and regulatory agencies to deliver compliant, safe products.

Qualifications

• Bachelor's and Advanced degree in related field, or equivalent work experience, preferred.
• 15+ years’ experience in related field, preferred.
• Direct people leadership experience managing quality professionals.
• Experience working within cGMP-regulated manufacturing environments, including compliance with 21 CFR Parts 210/211.
• Nuclear radiopharmaceutical and pharmaceutical experience required.
• Excellent communication and stakeholder management skills, with experience presenting quality performance, risks, and compliance matters to executive leadership, customers, and regulatory agencies.
• Experience serving as a primary quality representative during FDA inspections, customer audits, and regulatory reviews, with a track record of successful outcomes.
• Strong ability to collaborate with cross functional teams to drive desired outcomes.

Responsibilities

• Lead quality activities for radiopharmaceutical manufacturing and testing operations at the Aurora site.
• Oversee CMOs, FDA inspections, quality systems, and regulatory compliance.
• Lead the quality team and drive cross functional collaboration.
• Report to the Vice President of Quality Management.

Skills

Leadership

Communication

Stakeholder management

Cross-functional collaboration

Regulatory compliance

Education

Advanced degree in related field

Bachelor's degree in related field

Tools

FDA inspections experience

cGMP manufacturing

Regulatory compliance

Job description

Cardinal Health in Aurora, CO seeks a Director of QRA Management to lead all quality activities for radiopharmaceutical manufacturing and testing. This role oversees CMOs, FDA inspections, quality systems, and regulatory compliance, driving cross-functional collaboration across the site.

The successful candidate will manage a diverse team, ensure training and qualifications, and partner with executive leadership and regulatory agencies to deliver compliant, safe products.