Quality Assurance Manager

What Quality Assurance contributes to Cardinal Health

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Job Summary

The Manager, Quality Assurance manages quality programs, policies, and procedures in order to minimize risks and drive uncompromised supply chain integrity. Applying advanced knowledge of quality assurance concepts and technical capabilities, the Manager collaborates cross-functionally to develop solutions to complex quality issues and leads quality audits. When creating new standard operating procedures or making revisions to existing practices, the Manager is responsible for ensuring alignment within the organization and monitoring adherence to the policies. The Manager leads a team of Quality Assurance Specialists and manages the operations of the Quality Assurance department.

Responsibilities

• Manages internal Quality Assurance policies and programs to set guidelines for functions across the organization. Ensures fulfillment of external reporting requirements for products and operations.
• Leads a team of Quality Assurance Specialists. Delegates projects and specific work tasks, reviewing the work of others and providing specific direction to less experienced Specialists. Conducts performance evaluations for team members and makes recommendations to the Director regarding talent management and compensation.
• Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements. Assesses Quality Assurance implications and impacts of operational and product changes.
• Leads cross-functional projects to identify significant quality issue root causes, educate stakeholders on quality requirements, and develop solutions to minimize future risks. Works with Quality Assurance Specialists in a given area, such as recalls, to create recommended resolutions.
• Updates standard operating procedures in response to product changes and regulatory developments. Resolutions to significant quality issues, such as recalls or customer complaints, may set precedent for updates to SOPs.
• Serves as a liaison with regulators and responds to regulatory queries. Addresses questions and compiles necessary information during regulatory audits.
• Leads quality audits of distribution centers within the region to ensure operational compliance with standard operating procedures. Reports quality issues to Operations teams and provides guidance on improving processes.