Manager, Quality Assurance

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

• Primary focus will be supporting 3PL Partners within the Medical Segment.
• 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, applying knowledge of the Food & Drugs Act, Good Manufacturing Practice, and a variety of regulations related to medical devices, natural health products, drugs, and consumer goods.
• 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.
• Travel up to 10%

Qualifications

• Bachelor’s degree in related field, or equivalent work experience, preferred
• 8-12 years of experience, preferred
• Experience working with FDA regulations
• Manufacturing and/or distribution warehouse experience preferred
• Experience with ISO 9001 or ISO 13485 preferred

What is expected of you and others at this level

• Manages department operations and supervises professional employees, front line supervisors and/or business support staff
• Participates in the development of policies and procedures to achieve specific goals
• Ensures employees operate within guidelines
• Decisions have a short term impact on work processes, outcomes and customers
• Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management
• Interactions normally involve resolution of issues related to operations and/or projects
• Gains consensus from various parties involved

Anticipated salary range: $103,500-$155,295

Bonus eligible: Yes

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 04/28/2025 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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