Director, QRA Quality & Regulatory Compliance

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

Benefits offered by this job

Medical coverage

401k savings plan

Paid time off

HSA

Job summary

Cardinal Health in Aurora, CO, is seeking a Director of QRA Management to lead all quality activities for radiopharmaceutical manufacturing and testing, including oversight of CMOs, FDA inspections, quality systems, and regulatory compliance.

This role builds and leads the quality team, drives cross-functional collaboration, and reports to the VP of Quality Management. Requires 15+ years in the field, nuclear pharma experience, and strong leadership and regulatory engagement.

Qualifications

• Bachelor's/Advanced degree in related field or equivalent experience.
• Minimum 15+ years in related field.
• Direct people leadership experience.
• Experience in cGMP manufacturing and 21 CFR Parts 210/211.
• Nuclear radiopharmaceutical and pharmaceutical experience.
• Excellent communication with executives and regulators.

Responsibilities

• Provide Quality leadership for radiopharmaceutical manufacturing and testing.
• Oversee CMOs, FDA inspections, quality systems, and regulatory compliance.
• Review and approve batch records, deviations/investigations, complaints, change requests.
• Host FDA inspections and manage regulatory responses.
• Lead and develop a high-performing quality team.

Skills

Nuclear pharma

Quality leadership

Regulatory compliance

Cross-functional leadership

FDA inspections

Communication skills

Education

Bachelor's degree in related field

Advanced degree preferred

Job description

Cardinal Health in Aurora, CO, is seeking a Director of QRA Management to lead all quality activities for radiopharmaceutical manufacturing and testing, including oversight of CMOs, FDA inspections, quality systems, and regulatory compliance.

This role builds and leads the quality team, drives cross-functional collaboration, and reports to the VP of Quality Management. Requires 15+ years in the field, nuclear pharma experience, and strong leadership and regulatory engagement.