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 lifecycle.
- Uses sound judgment when automation output conflicts with physical observations, procedural requirements or regulatory expectations, and ensures appropriate escalation and documentation.
Expectations
- Applies advanced knowledge and understanding of quality, regulatory, operational and technical concepts to independently manage a wide variety of projects.
- Participates in and leads the development of policies and procedures to achieve specific goals.
- Recommends and leads implementation of new practices, processes, controls, metrics or models, including those enabled by automation and digital technology.
- Works on or may lead complex projects of large scope and cross-functional impact.
- Provides solutions that may set precedent.
- Independently determines methods for completion of new projects while receiving guidance on overall project objectives.
- Ability to support multiple Cardinal Health business units.
- Demonstrates adaptability, technical curiosity and comfort operating in a fast-changing, highly automated environment.
- Communicates technical and compliance risks clearly to both technical and non-technical stakeholders.
Responsiblities
- Maintain inspection readiness and objective evidence for quality, regulatory, security and automated process controls, including FDA, DEA, State Board of Pharmacy (SBOP), NABP and other regulatory inspections, audits and licensing activities.
- Ensure quality requirements are represented in automation-related change controls, risk assessments, investigations, CAPAs, procedures and training.
- Monitor trends and system outputs that may indicate process, data-integrity, chain-of-custody, product-quality or security risk.
- Coordinate timely cross-functional response to automation, technology or system events with potential regulatory or quality impact.
- Promote continuous improvement without compromising validated state, procedural control or regulatory compliance.
Qualifications
- Bachelor's degree in a related field, or equivalent work experience, preferred.
- 8+ years of experience in a related field, preferred.
- Experience in quality, regulatory, pharmaceutical distribution, highly regulated operations, supply chain or a comparable environment preferred.
- Demonstrated ability to understand and apply automated workflows, warehouse or enterprise systems, electronic records, data analytics, system integrations and technology-enabled controls.
- Proficiency with current pharmaceutical distribution ERP, WMS, QMS and reporting systems preferred.
- Experience supporting system implementation, validation, change control, data integrity, investigations or technology-related risk assessment preferred.
- Strong analytical, problem-solving, documentation and cross-functional communication skills.
- Ability to interpret technical information and explain its quality and regulatory significance to diverse audiences.
- Ability to travel as needed to support Cardinal Health distribution facilities, regulatory inspections, internal audits, training and cross-functional business initiatives.
Anticipated salary range: $106,700 - $137,160
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: 12/05/2026 *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.
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 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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