Quality Assurance Leader: Site Compliance & Strategy

RXinsider LTD.; Aurora, Northern (CO, KY); Hybrid; USD 118,000 - 168,000; Full time

Job summary

Cardinal Health is seeking a senior Quality Manager to lead the Quality organization at a site, overseeing policy development, regulatory compliance and team leadership. You will drive audits, manage staff, and report KPI metrics to corporate leadership.

The role emphasizes ensuring patient safety through rigorous product release decisions and continuous quality improvements. On-site work with typical day shift, with flexibility for scheduling needs.

Qualifications

• Manages department operations and supervises professional employees, front line supervisors and/or business support staff.
• Develops and implements quality policies, procedures and processes to ensure compliance with regulatory standards and specifications.
• Identifies trends and makes decisions affecting product release to ensure patient safety.

Responsibilities

• Develop and implement quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
• Provide strategic oversight, leadership and direction to direct reports within the Quality function.
• Manage, develop, train and guide direct reports, quality staff, and site personnel to achieve site quality goals and maintain regulatory compliance.
• Lead actions for regulatory, customer and corporate audits and customer technical visits and to provide responses to findings in a timely manner.
• Conducting Site Quality Management Reviews and report KPI metrics to corporate.
• Responsible for identifying trends and making decisions that affect product release to ensure patient safety.

Skills

People management

Quality management

Regulatory compliance

Education

Bachelor’s degree in related field

Job description

Cardinal Health is seeking a senior Quality Manager to lead the Quality organization at a site, overseeing policy development, regulatory compliance and team leadership. You will drive audits, manage staff, and report KPI metrics to corporate leadership.

The role emphasizes ensuring patient safety through rigorous product release decisions and continuous quality improvements. On-site work with typical day shift, with flexibility for scheduling needs.