Michel Keymolen

WORK HISTORY

EDUCATION

SKILLS

ABOUT MICHEL KEYMOLEN

As an all-round senior Project Manager and Quality and Governance Consultant, I am helping my customers within regulated and controlled environments to be more efficient by improving and transforming their processes, implementing and controlling IT/Computerized Systems/Applications in a compliant and secured manner and supporting IT Executive Management in their transition and technical and organizational change initiatives.Recognized by my peer as a polyvalent, multi-roles and “Swiss knife” team member.My focus today is set on:• Change Management,• Process Improvement,• Transformation.Experience• Project Management (Prince 2, PMI, Agile)• Computerized System Validation• Deployment of Commercial off-the-shelf using System Lifecycle Deployment Methodology• Process improvement and definition• Vendor Management• IT Quality Management• IT Governance and Compliance• Business Analysis and Requirements Analysis• Business relationship Management• IT Executive Management SupportActivities:• Project Management, coordination and follow up• IT Change Management• CAPA Management• IT Risk Management, IT Risk Assessment• Request for Information, Request for Proposal• Supplier Assessment and Qualification• System Documentation• Standard Operating Procedures (SOP)• IT Disaster Recovery Plan• Workshop Management• Training ManagementStandards and Frameworks:• Prince2• Agile• PMI PMBOK• ITIL• Microsoft Operations Framework (MOF)• ISPE GAMP 5• GxP• FDA 21 CFR Part 11• ISO ISO 9001• ISO ISO 27001, ISO 27002