Quality And Regulatory Operations Manager
CurrentServes as the primary liaison with local, state, and federal regulatory agencies, expertly managing inspections, investigations, and information requests to ensure full compliance.Verified and maintained all necessary licensures and registrations to support the business unit’s operational requirements.Managed Power of Attorney documentation and compliance for Schedule 2 order forms, overseeing the Order Monitoring Program (OMP) to meet corporate, state, and DEA standards.Ensured timely and accurate ARCOS and state reporting, managing correspondence with regulatory bodies regarding product losses and discrepancies.Fostered adherence to USP 1079 (GDP) standards, good documentation practices, data integrity principles, and effective storage, distribution, and transportation procedures.Partnered with business unit leadership to implement annual Quality Objectives and Key Business Drivers, promoting initiatives such as "Right the First Time," mistake-proofing, and DSCSA compliance.Supported the creation and monitoring of comprehensive training programs on Quality, Health & Safety, Security, and Regulatory standardsUtilized metrics and trend analysis to monitor and report on process performance, driving continuous improvement initiatives and identifying cost-saving opportunities.Prepared and presented monthly and quarterly metric reports for regional leadership, actively participating in quality metric meetings.Directed all aspects of the facility’s Health & Safety Program, enhancing security awareness and addressing potential security breaches and vulnerabilities.
