Overall Project Manager for the Global Roll-Out of a Quality and Document Management System

Professional Focus Areas

• Corporate Management, Interim Management, Project Management
• Controlled & Efficient Development Processes In Software And Hardware
• Quality Management, Compliance & Risk Management: Iso9001, Iso13485, Iso27001, 21cfr820, Gdpr, Gmp, Gamp5 Csv (Computer System Validation), Data Integrity, Iec61508 – Safety Critical Systems
• Certified Gdpr Consultant
• Iso9001:2015 Auditor

Professional Competencies

• Corporate Management / It Project Management: Project Planning, Scheduling, And Execution Of Complex It Projects, Leading Teams In Diverse Tasks: Infrastructures, Implementation Of Software Applications, Software Application & Product Development, Commissioning Of Control Systems
• Quality-critical Projects: Efficient Project Management While Meeting Critical Compliance Requirements – E.g. Traffic Telematics, Blood Bank Systems, Elga/ehealth, Pharmaceutical Manufacturing, Etc.
• Mission-critical Projects: Database Replications Across Multiple Sites, Distributed Dms (Document Management Systems), Data Consolidations, Distributed Systems And Organizations, Data Security And Security Solutions
• Monitoring And Adherence To Budgets, Milestones, And Effort Plans
• Project And System Documentation According To Selectable Qm Standards
• Improvement And Optimization Of Development Processes In Software And Hardware: Reducing Warranty Cases, Rework, And Support Loads
• Restoring Process Control, Documenting Legacy Systems
• Restoring Profitability, Billing Of Services
• Implementing Quality Management And Compliance According To Various Qm Standards
• Achieving Certifications, Approvals, Operating Licenses (Clients, Authorities)
• Simultaneous Compliance With Multiple Qm Standards, Safety And Risk Management In Complex It Projects
• Introduction, Adaptation, And Optimization Of Qm Systems
• Change Processes In Organizations, Procedures, And Responsibilities
• Audit Preparations, Conducting Internal And External Audits, Certification Audits, Representing Organizations To Authorities, Clients, Or Certifiers
• Project Management, Controlled & Efficient Development Processes
• Planning And Automation, Optimization Of Production Processes And Controls (Mainly Process Engineering)
• Interfaces With Erp Systems, Production Planning Systems For Material Usage Calculations And Optimization Tasks
• Implementing And Improving Qm Systems According To Iso9001:2015, Cmmi, Gdpr, En13485 Medical Technology, Design Controls 21 Cfr 820.30, Gamp5, Gmp, Csv (Computer System Validation), Cfr21 Part11, Data Integrity, Pic/s Guide
• Special Knowledge In Fail-safe And Safety-critical Systems Iec 61508
• Audit Preparations, Organization And Execution Of Internal And External Audits By Authorities Or Mission-critical Clients
• Trainings, Teaching Basics, Applications, And Best Practices
• Raising Awareness, Reorganizing Responsibilities, Supporting Change Processes (Change Management)
• Corporate Management, Business And Budget Planning, Recruiting And Building Teams, Developing New Business Areas
• Planning And Executing Mergers And Acquisitions
• Finding Investors And Company Financing
• Interim Management As Managing Director, Vice President, Department Head, Quality And Risk Manager
• Project Lead In Especially Mission-critical Projects
• Building, Reorganizing, And Securing Success In Sales And Development Departments
• Preparation, Execution, And Securing Of Acquisitions/mergers Both Personnel And Financial

Technical Competencies

• Applied Quality Management: Iso9001, En13485, Iso14971, Iso27001, 21cfr820, Iec61508, Gamp5, Gmp, Eu-gmp Guide Annex 11, Cfr21 Part11 Compliance, Data Integrity, Alcoa+, Cmm/cmmi, Gdpr
• Development: Microsoft Windows All Platforms; Vb, C/c++, C#, Java, Progress, Abap4; Sql; All Procedural And Object-oriented Languages (Fortran, Pascal, Modula-2, Chill, Etc.), Html, Java
• Development Tools: Microsoft Visual Studio, Subversion, Jira, Confluence (Atlassian)
• Databases: Microsoft Sql Server, Oracle (Database Replications)
• Applications: Ms Office, Ms Project, Ms Visio, Process4biz, Sap Is-h, Trackwise, Document Management Systems (Dms)
• Standards: Bpmn, Hl7, Ihe, Elga, Efa