External Operations Manager

Summary The External Operations Manager EOM is responsible for operational execution of clinical distribution with the focus on the external part of the clinical trial distribution supply chain The EOM Distribution oversees all outsourcing activities related to clinical distribution and functions as the key business partner interface with external vendors and ensures operational excellence within the CMO network ensuring the delivery of high productivity quality and cost effectiveness Has operational end to end responsibility for assigned activity Leads and manages all project and glob-al distribution network activities and participates in cross-functional teams Major Accountabilities Manages all applicable finance activities including Request for Proposal RFP for bidding vendor selection Grants Purchase Orders PO invoice approval and tracking financial metrics Assesses risks of the particular distribution strategy and provides guidance to the CTSM for distribution supply chain setup optimization Advises GCS Study Team on all relevant elements of clinical distribution to ensure optimal usage of available capacity and budget Drives the optimization of the general supply chain planning for development projects Manages order alignment with GCS Study team members to coordinate distribution order preparation and to ensure proactive resolution of any distribution order related questions Acts as the key business partner for operational interactions with the Vendors Reviews the vendor capacity resource planning and distribution tracker Is responsible for the setup management and development of the external distribution network Interacts with the CTSM and distribution vendor to flag potential issues or bottlenecks due to high demands seasonal situations or local regional issues Works closely with internal GCS Logistics team to ensure trade compliance to Novartis and general standards is adhered to also by the external distribution vendors Manages deviations occurring at external vendors and escalates high level issues bottlenecks to the relevant internal GCS stakeholders and external partners Participates or supports external inspections and audits together with TRD QA and GCP QA where applicable to assess distribution contractor capabilities Monitors and analyses vendor performance with pre-defined KPIs and collaborates with vendor to identify process optimizations and ensures timely follow up and completion of actions Being sub-process owner in GCS drives innovation in the areas of process simplification and cost reduction Contributes to productivity targets by continuously improve processes in own area of expertise Liaises with GCS counterparts to review project status Provides and analyses reports on various distribution as well as finance related topics Minimum Requirements 5 years of practical experience in chemical pharmaceutical industry or 3 years of experience in field of expertise Good expertise in related field Good knowledge about the Drug Development process Basic project management good organization and planning skills Knowledge of relevant regulations e g GMP HSE etc and Novartis specific standards Demonstrates problem-solving and idea generation skills Good presentation skills Fundamental Leadership skills Very good communication negotiation and interpersonal skills Ability to work in interdisciplinary teams Skills Desired Continual Improvement Process Master Data Material Requirements Planning Mrp Materials Management Production Planning Supply-Chain Management Supply Chain Planning Technical Requirements Waterfall Model Wms Warehouse Management Systems