Job Information
AmerisourceBergen Services Corporation Quality and Regulatory Manager in Cincinnati, Ohio
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details This role is supporting our AmerisourceBergen business, which offers supply chain services to healthcare providers and health systems in the United States. Under general supervision of the Regional Director, Quality and Regulatory Operations (QRO) with a dotted line to the Regional Director of Quality Assurance, responsible for assuring the business unit (BU) location maintains a robust, effective Quality Management System and security & regulatory compliance effort that aligns with Cencora' s policy and procedures, as well as state and federal regulations. This position will ensure compliance with the principles of Good Distribution Practices (GDP) and will have the authority and responsibility for ensuring the quality system is in a state of compliance and willfacilitateknowledge transfer throughout the operation to help build a Quality and Regulatory Compliance Culture. Responsible for the maintenance, execution, and monitoring of the BU Location's Quality Management System (QMS), Good Distribution Practices (GDP), and compliance with all local state (BOP, DOH, etc.),,and federal regulations (DEA, EPA, FDA, OSHA, etc.) as well as all corporate policies and procedures. Monitors, verifies, andmaintainsall BU location local, state, and federal licensure and registrations asrequired. Acts as primary liaison between BUlocationand all local, state, and federal regulatory agencies. Manages and/orassistswith all inspections, investigations, and information requests. Conducts required Quality, Health & Safety, Security and Regulatory Assessments. Promotes a culture of Quality across the BU location that ensures management commitment and understanding of USP 1079 (GDP), good documentation practices, Data Integrity, and GoodStorage, Distributionand Transportation practices. Responsible for collaborating with BU location on implementation of annual Quality Objectives (e.g., Right the First Time, Mistake-Proofing, DSCSA compliance) and Key Business Driversestablishedfor DC operations. Responsible for supporting and monitoring BU location Quality, Health & Safety, Security and Regulatory training. Supports development of BU location QMS componentse.g.RCA investigation, CAPA identification, and implementation, change control process, risk management, cGMPrefresher training. Utilize metrics and trend analysis to effectivelymonitorprocesses, report on performance, driveimprovementand provide cost savings to the BU location. Collaborate with Transportation on carrier-related issues where root cause analysis and corrective actions areinitiatedto improve carrier performance. Generate monthly and quarterly metric reports for regional leadership review. Attend andparticipatein Regional Quality metric calls/meetings. Represent Quality and Regulatory as a member of the BU location leadership team and Monitors and ensures compliance with corporate policy related to all temperature and security monitoring and alarm systems, access cards, key control, CCTV Manages andmaintainsall DC Power of Attorney documentation for all signers of Schedule 2 orderforms; Reviews Schedule 2 order forms (DEA Form 222s) to ensure complianceofSchedule 2 transactions. Monitors the AB Order Monitoring Program (OMP) at the BU location level to ensure compliance with all corporate, state, and DEA requirements. Reviews andverifiesthat all controlled substance and listed chemical inventories (daily counts, monthly, annual & biennial) are comple