Germany
Experience since 2005 in leading, managing, implementing and rolling out globally IT Solutions in Pharma & Medical Devices for Quality, Clinical and Regulatory. Expertise: • Good Documentation Management Practices (SOP Management, Quality & Regulatory Record Management, Retention Management) • Quality Management Practices in Pharma & Medical Devices CFR 210/211, 820 / EU GMP / ISO 13485 • Regulatory Management Process in Pharma & Medical Devices FDA / EMEA • Clinical Operations in Pharma • Leadership in Global IT Roll-outs • E-Procurement Best Process Practice in LifeScience, Financial Services and Electronic Equipment Manufacturing Specialties: Leading and Managing (Malik Management school) organizations with a rich set of skills in o Strategy Definition and Planning o Change Management (ChangeSetter, Strategic Visioning) o Project and Program Management (Prince2 certified) o Management of IT Operations (esp. in regulated Environments) o Validation management (ECA certification) o Requirements Management (CREB) Technologies: EMC DOCUMENTUM, D2, MS SharePoint. TRACKWISE, QLIKVIEW, SAP R3 (MM)
Leading high-performance, agile Data & AI Acceleration squads to deliver scalable Data and AI solutions, pilots, and MVPs that drive executive decision-making. Empowering FME's business and G&A functions within the medical device sector to scale a global, data- and AI-first culture in close alignment with IT, digital technology, and innovation hubs.
Leading a digital transformation journey for the quality management processes in the manufacturing operations in EMEA, Latin America and Asia Pacific to improve global compliance and cost of good quality. Continue leading the programs Quality Documentation and Quality Reporting. Managing program and operations of cross regional Quality Business Application (NC, CAPA, Complaints) with 2500+ trained users. Supervision of IT Governance and Software Validation function for Computerized Systems.
Continued leading the cross regional quality documentation program and ensured its deployment to major key manufacturing operations and operational support with more than 1000 trained users. Established Documentation Office to support of Cross Functional Quality Management System implementation. Secured close alignment with Global Product Data Management Program to ensure process alignment and regulatory fit for documentation. Developed Strategy and Program for Global Quality Data-warehouse for modern Quality Reporting and predictive Quality Analytics and supervised its implementation during 2017.
Support Lifescience Organizations implementing Information Managment Solutions to become more efficient and more effective. Responsible for Business Consulting Services Team o Project Management o Business Analysis / Requirements Engineering o Change/Transformation Management o Test & Release Management o Computerized System Validation Projects: o Management of Pre-Study & Roll-out Implementation for Global Quality Documentation Solution, Global Pharmaceutical Manufacturer o Management Support for Implementation & Roll-out of Global Quality Management System, Medical Device (US & Germany) o Management of Document Management Introduction Project, Device Manufacturer o Management of Pre-Study Global Manufacturing KPI & Analytical Reporting Project, Global Pharmaceutical Manufacturer o Management Support for Clinical Trail Investigator Portal Program with Integration to Regulatory Submission Management, Global Pharmaceutical Manufacturer DOCUMENTUM, TRACKWISE, QLIKVIEW, INNOVOCOMMERCE, SAP MM
Responsible for IT Applications and Platforms, 2 Teams, 10+ people located in Sweden and Hechingen o Global Quality Management Solution Platform with Analytical Reporting, used worldwide for Post Market Surveillance, CAPA and Audit Management. 700 users 13 Sites o 12 Enterprise Content Management Platforms used worldwide for Collaboration, Publishing, Doc Control, Labeling, Contract Management, 1500 users o Global eLearning Service, used worldwide with 2500 users o IT Solutions supporting Clinical Trails o Technologies: DOCUMENTUM, TRACKWISE, QLIKVIEW, eROOM, SHAREPOINT, JAVA, .NET, XML, AS2 Messaging, MSSQL, MICROSOFT SERVER
• Responsible for several IS Applications and Platforms, 10+ projects/year, 2 Project Teams, 15+ people located in Frankfurt and Paris, yearly Budget >5M$ o Global Document Management Platforms for controlled Documents and non-controlled Documents , 6000+ trained users, used with in 25 Sites, globally 40.000 signatures/month, integration with local ERP Systems DOCUMENTUM 5 & 6, ADOBE, JAVA, HP-UX, WINDOWS 2003, ORACLE, CFT o Global Quality Process Platform Processes: Supplier Audits, Risk Management, Deviation Management, eCAPA and Change Control) for currently 1500 users used in over 80 sites. TRACKWISE, ORACLE, CRYSTAL REPORTS o Automated Functional Testing, IS Change control, IS Incident Management, IS Release Management System, SERENA DIMENSIONS, HP/MERCURY QUICKTEST, SERENA TEAMTRACK,, CRYSTAL REPORTS, ORACLE
* • Responsible for operation and support of an Global e-Procurement Platform 20.000 users, integrated with 18 SAP system in 24 countries, Team with 10+ people located in France, US and Germany ARIBA BUYER, ARIBA SOURCING, TIBCO, SAP, JAVA, HP-UX, ORACLE, CFT • Achievements: o Build up and established a global 24h Support organisation o Managed established SLAs and managed Services Delivery according to agreements and KPIs o Coordinated and managed several Go-Lives and Migration Activities o Setup up and implemented Quality Improvements and Efficiency Programs o Organized and performed Workshops for technical ARIBA SOURCING o Actively driven Supplier Relationship