Associate Director Trade Operations And Compliance
Current•CoE Winner 2023.•Sobi North America Trade, Distribution, and Compliance Operations working with three 3PLs, 7 Specialty Distributors, 21 Specialty Pharmacies, and 3 Hubs.•Support and implemented Drug Design shift from Open Full Line Wholesale to Specialty Distribution and Pharmacy Networks to limited/closed Distribution Networks achieved minimal disruption and ATP compliance •Oversee the distribution/logistics for storage import export distribution destruction and 3PL management of drugs achieving high service level results and inventory accuracy with DSCSA compliance.•Manage Class of Trade for appropriate Access.•Support/ Collaborate with multiple internal/external corporation teams relating to projects such as:•product Launches USA and Canada.•Drug Distribution management program and Drug Product Market Withdrawal•Dissolving of Pharmaceutical Company•Drug BLA transfer•FDA EUA•Successful switch of 3PLs•Negotiations (MSA/SOWs) collaborating with Quality, PV, Legal, and Finance Teams for compliant contracts and to Fair Market Value (FMV)•Managed/Created Company initial programs and successful compliance reporting relating to:•Drug Product Information/pricing to Drug Compendia•Drug Take Back Program•State Price Transparency Reporting and Prescription Drug Affordability Boards•Ensure appropriate State Licensing -Company Designated Representative•Conduct annual inventory counts •Implemented new Qualified Shipper packouts for Temperature control reduced shipping costs•Supported S&OP process partnering with End to End Team (E2E) and Tech Ops for:•Minimize product wastage•Maximize product usage from DS to DP to FG•Avoid Drug Product Stock Outs.•Ensure of On Time inbound inventory receipt.•Report in QMS any quality event deviations and supports closure •Updated Returns Policy and created Product Replacement Policy to State and Government Regulations.•Performed Vendor Quarterly Business Reviews with Specialty Distributors and 3PLs.