Highly motivated professional with 15+ years of experience in IT and Regulatory Licensing operations for pharmaceutical companies specializing in the manufacturing and distribution of Legend Drugs and Devices. Recognized on a regular basis for team leadership, planning and organizational skills. Dedicated to partnering with coworkers to promote engaged, empowering work culture.
• Researches and interprets current and pending federal and state regulations pertaining to movement, distribution, and sale of prescription drugs and devices.
• Maintains all applicable wholesale distribution and/or manufacturing licenses and accreditations for Distribution and Manufacturing establishments to receive, store, and ship prescription drugs and devices.
• Coordinates required licensing applications, background checks, and general documentation for Designated Representatives applicable to wholesale licensure requirements.
• Manages team projects pertaining to licensing related personnel changes congruent with the requirements of state regulations.
• Corresponds with federal and state licensing authorities as needed.
• Maximizes performance by monitoring daily activities and mentoring team members.
• Responsible for onboarding activities for new hire employees.
• Cross-trains existing employees to maximize team agility and performance.
• Defines clear targets and objectives and communicates to other team members.
• Initiates and facilitates processes with Distribution Center personnel for conducting NABP Drug Distributor Accreditation (DDA) review and Supply Chain Inspection activities.
• Supports internal and external departments with any facility, customer, and/or vendor licensing inquiries.
• Complies with Drug Supply Chain Security Act and current Good Manufacturing Practices.
• Originates and maintains license verification activities in SAP for upstream and downstream Authorized Trading Partners, confirming and documenting license status in format required by federal and state licensing authorities.
• Lead the maintenance and administration of current ERP and logistics systems in partnership with internal resources.
• Supported leadership team with reporting, analysis, and business presentations to inform divisional strategies.
• Interacted with cross-functional teams to ensure business processes and rules were documented to ultimately determine areas for improved efficiencies.
• Researched and recommended new technology solutions aligned with industry standards.
• Supported operations/logistics information systems team in performing system testing, system implementations, business process improvements, system upgrades, system optimizations, production activities, and end-user engagement improvement initiatives.
• Provided analytical and technical support to team members and end-users in defining and documenting system processes, data flow, controls, and interfaces for financial information systems.
• Gathered and analyzed customer requirements. Drafted clear and concise functional design documentation, testing plans, and scripts.
• Ensured functional work activities were conducted in compliance with technology and GMP requirements, related policies and procedures, and corporate objectives.
• Maintained all applicable wholesale distribution and/or manufacturing licenses and accreditations for 14 Distribution Centers and 5 Manufacturing Plants to receive, store, and ship prescription drugs and devices.
• Researched and interpreted current and pending federal and state wholesale distribution regulations pertaining to movement, distribution, and sale of prescription products that could impact business; identified need for SAP enhancements to ensure company compliance with regulations.
• Completed and managed submission of initial and renewal license applications to appropriate federal and state licensing authorities.
• Compiled documentation for Annual Compliance Review and 3-Year Reaccreditations for 8 NABP DDA accredited facilities.
• Originated and maintained license verification activities in SAP for upstream and downstream Authorized Trading Partners, confirming and documenting license status in format required by federal and state licensing authorities.
• Mentored new and junior team members on a consistent basis.
• Ensured stabilization of ERP system (SAP) within Distribution Center network.
• Spearheaded initiatives to improve functionality of SAP for Distribution Center network.
• Developed process flows for Supply Chain initiatives and assisted in project justification.
• Managed projects for SAP enhancements implemented within Distribution Centers.
• Worked with various types of programmers to perform SAP solution validation and facilitated testing.
• Worked closely with Quality Department to identify, analyze, and implement opportunities to improve overall Distribution Quality Compliance.
• Liaised between back-office system users with Distribution Centers to streamline order to cash supply chain management process.
• Created Test Scripts, SAP User Procedures, Training Curriculum, and Work Instructions for training sessions with all levels of end-users.
• Used ERP system (SAP) to control all inventory within Distribution Center.
• Performed daily cycle counts to ensure inventory accuracy.
• Processed all returned goods coming back to warehouse.
• Supported router and pharmacist with all inventory issues relating to outbound deliveries to clinics and patients.
• Tracked all inventory movements for monthly KPI's and reported data in monthly staff meeting.
• Initiated and executed strategies to eliminate product damage and waste.
Lean Six Sigma, Yellow Belt Certification
Lean Six Sigma, Yellow Belt Certification