Manager, Quality Assurance

OH-Ohio-FIELD

Full time

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

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

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

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

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

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

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

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

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** Document Management in Vault (Quality Docs):
** 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.

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

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** 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.

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** 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).

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

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** Pharmacovigilance & AE Minimum Data Set Collection:
** Ensures intake records capture the ICH E2D minimum data set for…