General Management• Accountable person for entire software tasks within the project.• Ensures consolidated reporting and communication for all software relevant topics to the development project leader (Dev PL).• Constant optimization of processes within the software project to improve quality and efficiency. Project Management• Responsible for the definition and implementation of the organizational structure and the working rules within the software project.• Tailoring and implementation of software project processes and best practices in the project context including software project deliverables. • Accountable for software project planning and monitoring deliverables.• Accountable for software detail planning (time line, deliverables, resources and quality) and capacity planning based on the project plan and effort estimations • Managing software project budget. Communication • Ensuring efficient and effective communication and information flow within the software project.

•MBO/Targets for direct reports•Recruiting including coordination and planning•Regular meeting for team members and individual personnel•Facilitating System integration to meet requirements and specifications within agreed timelines•Supporting the System Integration team in their work estimates, design and implementation decisions•Ensure design, implementation, documentation and testing is carried out in accordance to Quality Assurance Procedures

• Responsible for planing and execution for Verification and Validation• Creating the specified documents and compliance with FDA guidelines and qualitystandards• Key-stakeholder in several Quality assurance bodies