Manager, Quality Management West

　　West Region

　　What Quality Management 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 Management provides strategic oversight, leadership and direction within the Quality function.

　　Primary Job Function

　　The Regional Quality Manager (RQM) is primarily responsible for:

　　Providing general oversight to ensure the identity, strength, quality and purity of the drug product released at their sitesEnsuring that all raw materials and finished product meet specificationsEnsuring the review of production records and release of finished product at their assigned sitesEnsuring that all procedures are followed and that all errors and failures to meet specification are appropriately investigated and corrected at their sitesEnsuring regional quality coverage at all assigned sitesResponsibilities:

　　The RQM:

　　Provides overall direction and management of the QA function that supports their assigned PET manufacturing sites in the United States.Is responsible for all Quality Assurance functions including but not limited to: raw material storage activities, batch record review and approval, product disposition, investigation and remediation of manufacturing issues according to procedure, compliant investigation, execution of validation protocols and site related records management.Provides advice, guidance and training to QA staff in the verification and approval of documents and processes including but not limited to: validation protocols / reports, investigations, procedures and change controls.Interacts with regulatory agencies, as necessary and ensures the closure any regional FDA commitments on time and its relateddocumentation/objectiveevidence appropriate.

　　Ensure that the procedures are properly followed and adequate for their intended use.

　　Implements and monitors quality performance measures for the site and reports them to the Director, Quality in a timely manner.

　　Interacts with and provides advice to management and other personnel in the establishment of systems, plans, specifications, methods and procedures.

　　Assess data collected (complaints, investigations, change control, stability failures, etc.) to identify trends and develop corrective actions where needed to ensure compliance with cGMP’s and regulatory requirements.

　　Collaborates with their assigned Area Manager and others to build strategic alliances within the PET network; negotiates to build broad-based support and/or persuades others in order to meet deadlines.Identifies opportunities to improve efficiency while providing flawless transactions, services and products; manages monetary assets and other resources to optimize cost effectiveness.Ensures that customers have a positive experience; commits to meet or exceed customer expectations.Qualifications:

　　B.S. in a science related discipline preferred2-5 years of experience in the Pharmaceutical Industry.1-3 years of experience in a quality management role.Thorough knowledge of FDA regulatory requirements, controlled environments, good manufacturing practices and quality system requirements.Knowledgeable to validation practices and principles.Ability to travel to all assigned sites (50-75%).Required Competencies

　　Excellent interpersonal, organizational and communication skills.Demonstrated leadership and the ability to motivate and influence others.Proficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations, etc.Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices.Level of Authority

　　The RQM has the authority to:

　　approve change control documents (up to a moderate change)

　　initiate investigations and provide direction for corrective actiondetermine, develop and deliver trainingdevelop, review and revise quality proceduresmake hiring decisions for their direct reportsapprove personnel related issues (PTO, travel, etc.)deploy employee goals, objectives and performance evaluationscarry out other duties as described in policies and procedures or as assigned by the Director/QualityAnticipated salary range: $102,000 - $145,700

　　Bonus eligible: Yes

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

　　Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication window anticipated to close: 03/15/2024 *if interested in opportunity, please submit application as soon as possible.

　　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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　　We are a team of nearly 48,000 mission-driven partners striving each day to advance healthcare and improve lives. We are Essential to care.

　　Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for health care facilities

　　We are a crucial link between the clinical and operational sides of care, working with more than 4,500 sourcing and manufacturing partners to deliver end-to-end solutions and data-driven insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care.

　　With 50 years of experience, approximately 44,000 employees and operations in more than 30 countries, Cardinal Health seizes the opportunity to address healthcare’s most complicated challenges — now, and in the future.

　　On Thursday, Jan. 7, 2021, we celebrated the day our founder, Bob Walter, had the vision to start a business that became known as Cardinal Health.

　　One of the most important ways we celebrated was by giving back to the communities where we live and work. 2021 was a "Year of Service” for all Cardinal Health employees around the world.

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　　Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.