Quality Compliance Manager

Location: Whitestown

IN-Whitestown-Logistics Park Northwest

Full time

** What Regulatory Management Contributes*
* Quality Compliance Management is responsible for the development and deployment of policies, procedures and programs designed to minimize risk, enable compliant business operations, products and services, and drive uncompromised supply chain integrity.

** Overview of Role*
* Demonstrates knowledge of regulatory requirements and applies quality, operational, technical and data-driven judgment to assess regulatory change, risk and business impact in a highly automated distribution environment.

Responsible for implementation and execution of the Cardinal Health Quality System at one or more Cardinal Health distribution facilities, including pharmaceutical, medical or Cardinal Health at-Home distribution operations.

+ Provides oversight and direction for regulatory inspections, investigations, nonconformances, complaints, CAPAs and effectiveness monitoring to ensure timely resolution and sustained compliance.

+ Leads and directs efforts to assess Quality Management System implementation, drive performance improvement and enhance supply chain integrity while preserving and optimizing system efficiency.

+ Develops, implements and maintains standard operating procedures, programs and processes to ensure conformance with quality, regulatory and company requirements.

+ Applies thought leadership and expertise to assess, evaluate, manage, mitigate and balance risk while enhancing business performance.

+ Provides ongoing guidance and direction to operations personnel regarding regulatory and quality matters.

+ Monitors federal, state and local regulatory activity to implement new company procedures or update existing procedures to facilitate compliance.

+

May have one or more direct reports and/or oversight of a quality department within a facility.

+ Serves as liaison with local, state and federal government agencies.

** Automation, Technology and Data Expectations*
* + Develops a practical understanding of automated storage and retrieval systems, conveyor-based material movement and robotic or system-directed workflows, and evaluates how these technologies affect product quality, controlled-substance security, traceability and regulatory compliance.

+ Partners effectively with Operations, Engineering, IT, Security, Loss Prevention, system vendors and QRA stakeholders to support qualification, validation, change control, issue escalation and compliant implementation of automated systems.

+ Understands and uses technology-enabled chain-of-custody controls, including camera checkpoints, barcode and OCR data, tote and pallet identity, timestamps, custody logs, alerts and system-generated records.

+ Oversees the review and interpretation of data from smart analytics, security camera platforms, warehouse systems, dashboards and automated audit trails to identify anomalies, investigate events, assess risk and support evidence-based decisions.

+ Provides quality oversight for automation or technology-related deviations, alarms, system failures, exceptions and human-tampering alerts, including evaluation of product impact, containment, investigation, CAPA and effectiveness monitoring.

+ Assesses data integrity, access, record retention, traceability and audit-readiness requirements for electronic records and system integrations supporting regulated operations.

+ Learns new systems quickly and translates technical concepts into clear procedures, training, controls and inspection-ready explanations

+ Provides quality and regulatory oversight for system design reviews, testing, implementation, process monitoring and continuous improvement to ensure quality and regulatory requirements are incorporated throughout the technology…