Quality Compliance Leader – Regulatory & Automation

Cardinal Health; Whitestown (IN); In loco; USD 107.000 - 137.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

FlexPay

Flexible spending accounts (FSAs)

Short- and long-term disability covera

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Descrizione del lavoro

Cardinal Health is seeking a Regulatory Management professional to lead quality compliance across distribution facilities. You will implement and oversee the Quality System, guide regulatory inspections, CAPAs, and change controls, and partner with Operations, IT, and engineering to ensure compliant, efficient automated processes.

Responsibilities include maintaining inspection readiness, monitoring data integrity, and delivering evidence-based improvements while balancing risk and business

Competenze

• 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.

Mansioni

• Maintain inspection readiness and objective evidence for quality, regulatory, security and automated process controls, including FDA, DEA, 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.

Conoscenze

Regulatory requirements

Quality systems

Data analytics

Cross-functional communication

Risk assessment

Formazione

Bachelor's degree or equivalent

Strumenti

ERP

WMS

QMS

Reporting systems

Descrizione del lavoro

Cardinal Health is seeking a Regulatory Management professional to lead quality compliance across distribution facilities. You will implement and oversee the Quality System, guide regulatory inspections, CAPAs, and change controls, and partner with Operations, IT, and engineering to ensure compliant, efficient automated processes.

Responsibilities include maintaining inspection readiness, monitoring data integrity, and delivering evidence-based improvements while balancing risk and business