Quality Assurance Manager — Regulatory & Site Leadership

Cardinal Health; Aurora (CO); On-site; USD 117,700 - 168,100; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid time off

401k savings plan

Health savings account (HSA)

Short- and long-term disability

Paid parental leave

Work-Life resources

Job summary

Cardinal Health in Aurora, CO seeks an experienced Quality Assurance Manager to lead regulatory compliance, quality systems, and site audits. You will oversee staff, develop policies, and drive KPI reporting to corporate leadership.

The role requires 8–12 years in quality management, a related bachelor's degree, and proven ability to manage audits, document control, and cross-functional collaboration in a regulated manufacturing environment.

Qualifications

• Minimum 8–12 years of experience in quality assurance or related field.
• Bachelor’s degree in a related field or equivalent work experience preferred.
• Experience leading audits and regulatory inspections is expected.

Responsibilities

• Develop and implement quality policies, procedures, and processes to meet regulatory standards.
• Provide strategic oversight and direction to quality staff and site personnel.
• Lead regulatory, customer, and corporate audits and respond to findings in a timely manner.
• Conduct Site Quality Management Reviews and report KPI metrics to corporate.
• Identify trends and make decisions affecting product release to ensure patient safety.

Skills

Quality management

Audits

Regulatory compliance

Leadership

Training

Education

Bachelor’s degree in related field

Job description

Cardinal Health in Aurora, CO seeks an experienced Quality Assurance Manager to lead regulatory compliance, quality systems, and site audits. You will oversee staff, develop policies, and drive KPI reporting to corporate leadership.

The role requires 8–12 years in quality management, a related bachelor's degree, and proven ability to manage audits, document control, and cross-functional collaboration in a regulated manufacturing environment.