Quality Compliance Manager

Cardinal Health•Whitestown, IN

4d•$106,700 - $137,160

About The Position

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. This 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. The position is responsible for the 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. It provides oversight and direction for regulatory inspections, investigations, nonconformances, complaints, CAPAs and effectiveness monitoring to ensure timely resolution and sustained compliance. The role leads and directs efforts to assess Quality Management System implementation, drive performance improvement and enhance supply chain integrity while preserving and optimizing system efficiency. It develops, implements and maintains standard operating procedures, programs and processes to ensure conformance with quality, regulatory and company requirements. The role applies thought leadership and expertise to assess, evaluate, manage, mitigate and balance risk while enhancing business performance. It provides ongoing guidance and direction to operations personnel regarding regulatory and quality matters. The role monitors federal, state and local regulatory activity to implement new company procedures or update existing procedures to facilitate compliance. The position may have one or more direct reports and/or oversight of a quality department within a facility. It also serves as liaison with local, state and federal government agencies.

Requirements

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.

Responsibilities

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.