Manager, Quality Assurance

OH-Ohio-FIELD

Full time

20187007

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 operational procedures in order to minimize risks and drive uncompromised supply chain integrity across Cardinal Health operations and private label pharmaceutical product lines. Applying advanced knowledge of quality assurance concepts, cGMP/cGDP regulatory requirements, and technical capabilities, the Manager collaborates cross-functionally across Legal-Regulatory, Operations, Supply Chain, and Commercial teams to resolve complex quality issues, execute change management workflows, and lead quality audits.

The Manager serves as a primary QA Approver, Change Control Owner/Coordinator, and process overseer within the Veeva Vault Electronic Quality Management System (eQMS) for Cardinal Health Pharmaceutical Private Label (CAHPPL). The Manager oversees complaint intake and processing for private label portfolios (including Major Pharmaceuticals, Rugby Laboratories, LEADER, Assist, and Bulk-Up), administers Master Repackaging Record change requests, and manages Veeva Vault change controls, SOPs, and temporary/emergency change workflows. Additionally, the Manager leads a team of Quality Assurance Specialists and manages day-to-day Quality department operations.

Responsibilities

• Team Leadership: Supervises Quality Assurance Specialists, delegating work tasks, setting performance goals, conducting evaluations, and providing guidance on complex quality issues.

• Departmental Operations: Manages department operations and supervises professional employees, supervisors, and support staff.

• Policy & Procedure Execution: Participates in developing and executing policies and procedures to achieve specific quality and compliance goals.

• Operational Adherence: Ensures all supervised employees and cross-functional teams operate within established quality and regulatory guidelines.

• Business Impact: Decisions have direct operational and regulatory impact on work processes, quality system outcomes, customer satisfaction, and product compliance.

• Cross-Functional Interaction: Interacts regularly with direct reports, peers, customers, suppliers, and regulatory bodies across various management levels.

• Problem Resolution: Focuses interactions on resolving technical quality issues, operational deviations, change controls, and project deliverables.

• Consensus Building: Successfully drives consensus among cross-functional stakeholders including Regulatory, Stability, Supplier Management, and Operations teams.

• Document Management in Vault (QualityDocs): Manages the authoring, revision, periodic review, and approval of SOPs, Work Instructions, Form Templates, and User Guides in response to operational changes, packaging updates, or regulatory developments.

• Procedure Alignment: Ensures standard operating procedures accurately reflect daily execution across call center intake, quality product support, change control workflows, and distribution center operations.

• Complaint Intake Management: Oversees complaint intake workflows for CAHPPL brand portfolios (Major Pharmaceuticals, Rugby Laboratories, LEADER, Assist, and Bulk-Up) to ensure strict adherence to procedures and processing timelines.

• Complaint Triage & Categorization: Classifies intake contacts in Veeva Vault into specific types and subtypes (Labeling Complaints, Packaging Complaints, Product Quality Complaints [PQCs], Inquiries/Follow-Ups [IFUs], and Not Product Quality Complaints for eCommerce shipping or case label issues).

• Adherence to Processing Timelines: Enforces strict intake processing timelines.

• Pharmacovigilance & AE Minimum Data Set Collection: Ensures intake records capture the ICH E2D minimum data set for Adverse Events (identifiable patient, identifiable reporter, suspect product, suspect adverse event) and oversees follow-up inquiries with reporters.

• Call Center & Third-Party Interface Oversight: Manages operational touchpoints with the external call center and Product Support, providing Master Product Datasheets and Item Lists, tracking Caller Identification Numbers (CINs), and ensuring manual intake contingency workflows are executed and transcribed into Vault during system downtime.

• Promotion to Complaint Records: Ensures completed intake records are validated and promoted to full Complaint Records for secondary processing and investigation per SOP-04886.

• Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.

• CAHPPL Change Control Oversight: Serves as Quality Assurance (QA) Approver / Final QA Approver, Change Control Owner, or Change Control Coordinator in Veeva Vault, executing and approving change controls for New Product Launches (NPL), new NDC/UPC or item numbers, repackaging site changes, Approved Supplier List (ASL) updates, and planned deviations.

• Temporary & Emergency Change Controls: Oversees Temporary Change Controls with defined life cycles and expiration dates, as well as Emergency Change Controls for immediate regulatory or operational corrections (coordinating pre-approvals and QRA Director approvals).

• End-to-End Change Control Life Cycle Management: Manages change records through all Vault processing states ( Initiated , In Impact Assessment , In Change Plan Finalization , In Change Plan Approval , In Change Execution , In Final Approval , and Closed ).

Qualifications

• Bachelors in related field, or equivalent work experience, preferred

• 8+ years' experience in related field, preferred

• Demonstrated knowledge of 21 CFR Parts 207, 208, 210, 211, and 820, cGMP, cGDP, and ICH E2D guidelines.

• Proven experience managing Master Repackaging Records (MRR), technical change control impact assessments, and adverse event/complaint intake workflows.

• Demonstrates knowledge of quality systems and approaches.

• Demonstrates an understanding of the relevant regulations, standards and operating procedures.

• Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.

• Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.

• Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.

What is expected of you and others at this level

• Manages department operations and supervises professional employees, frontline 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, peer customers and suppliers at various management levels may interact with senior management

• Interactions normally involves resolution of issues related to operations and/or projects

• Gains consensus from various parties involved

Anticipated salary range: $106,700-$152,400

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: 10/30/2026 *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.

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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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 healthcare facilities.

We are a crucial link between the clinical and operational sides of healthcare, delivering end-to-end solutions and data-driving 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 more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges - now, and in the future.

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