Profile- Highly experienced IT & SAP Project Manager in the controlled, discrete, and process industries.
- Highly experienced CSV & QA Lead, Expert in GxP / GAMP in the Pharma-, Biotech-, MedTech Industry
- SAP Implementation, SAP ERP, S4/Hana, Pharma IT Project Management, Pharma QA, Pharma Computer System Validation, Proven success in implementing complex projects in time and within budget.
- Many years of experience as Validation Lead, QA Expert, responsible for computerized systems validation (CSV), Quality implementation (GxP)
Skills- Team leadership & management
- Scrum Master
- Program execution
- Agile Projects
- Strategic planning and implementation
- Test Management
- Process improvement
- Budgeting & financial management
- Business Development
- Cross-functional collaboration
Work Experience2021 - todayRole: Project- and Program Manager
Customer: Independent, mainly in the Pharma/MedTech industry
Tasks:- Project Management: Rollout and implementation of international IT Projects; including financial- and team management and responsibility
- Projects include diverse SAP ERP; SAP S/ 4HANA; cloud/on-premise
- Responsible for project Computerized System Validation (CSV), QA, project quality
- Implementation of CSV, QA in the project
- Business Development: scouting for new projects and opportunities
- Key Account Management; Responsible for all client projects and offerings
- Development of RFIs and RFPs
2017 - 2021Role: Principal Consultant
Customer: Infosys Consulting, Germany
Tasks:- Project Management (including finance and team management)
- Responsible for project Computerized System Validation (CSV), QA, project quality
- Implementation of CSV, QA in the project
- Team management (Teams of 24 Consultants), including coaching and mentoring of team members
- Rollout and implementation of international IT (including SAP) Projects
- Leading MFG, SCM, QM and Finance IT projects
- Business Development and scouting for new projects and opportunities
- Development of RFIs and RFPs
2013 - 2016Role: Lead/ Senior Consultant and Team Leader
Customer: Altran Consultancy, Germany
Tasks:- Project leadership/-coordination
- Validation Team lead (Implementation and responsibility for all project CSV, QA, project quality)
- Team Leadership and coordination (Team of 4 consultants)
- Implementation of Pharma and Medtech SAP, ERP IT projects
- Planning and implementation of pharmaceutical production processes
- Auditing pharma companies and production processes
- Consultancy services for Gap analysis and industry best practice implementation in pharmaceutical industry.
2012 - 2013Role: Consultant
Cusotmer: IDS Scheer Consultancy, Germany
Tasks:- Auditing pharma companies and production processes
- Consultancy services for pharmaceutical companies, GAP analysis industry best practices
- Consultancy services for pharma industry business process transformation and business process optimization
- Consultancy services for SAP solutions
- Planning, implementation and controlling of pharmaceutical production processes
- Business Development and new customer acquisition
1996 - 2012Role: Previous Positions
Customer: Previous Positions on request, or as per my online Profile