Michael Berger
IT Project Manager, QA & CSV Expert
1 recommendation
Salary / Daily rate
1 person recommend
Germany
Freelance, open to permanent contract
Skills
Languages
About me
Intro
International IT Program & Project Manager | GxP Validation Lead | SAP S/4HANA | Cloud | AI | CSV Expert I am an experienced IT Program and Project Manager as well as Validation Lead with more than 15 years of international experience delivering large-scale SAP, Cloud, and AI transformation programs for global leaders in the pharma, biotech, medtech, and manufacturing industries. My background combines program delivery, validation leadership, and compliance expertise. I have managed budgets up to €3.5M and teams of 60+ consultants, successfully implementing SAP S/4HANA, ERP, and AI/ML solutions in highly regulated GxP environments. As a GxP Validation Expert (CSV, QA, GAMP, cGCP), I have led validation activities end-to-end — from strategy and documentation to audits and release — ensuring regulatory compliance while enabling operational efficiency and digital transformation. Key areas of focus: • IT Program & Project Management (SAP, AI, Cloud, ERP) • Computerized System Validation (CSV), QA, GxP Compliance • Validation Leadership in Pharma, Biotech & Medtech Projects • SAP S/4HANA Implementations (Greenfield, Brownfield, Rollouts) • Cloud Architecture & Data Integrity (Private/Public/Hybrid) • Agile, Waterfall & Hybrid Project Methodologies • Stakeholder Management (incl. Executive & C-Level) • Business Development, RFI/RFP Management I am open to international program management or validation lead roles — ideally remote or hybrid — where I can combine my delivery experience and validation expertise to drive compliance, efficiency, and innovation.
Work experience
IT Project Manager, QA & CSV Expert
Independent Consultant
Apr 2024 - Present
2 years 7 months
Germany, Switzerland
Management Consultant and Project Leader
MAIN5
Oct 2021 - Dec 2023
2 years 3 months
Frankfurt, Germany
Project- and Team Manager
Infosys Consulting
Jan 2017 - Oct 2021
4 years 10 months
Project leader Team leader Responsible for international IT Rollouts Responsible for Computer System Validation SAP IT projects Pharmaceutical Process Validation Business Process Optimization
Principal Consultant
Infosys Consulting, Germany
Jan 2017 - Jan 2021
4 years 1 month
Project Management (including finance and team management) 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 Responsible for project Computerized System Validation (CSV), QA, project quality
Lead Consultant Team and Project Leader
Altran
May 2013 - Dec 2016
3 years 8 months
Project leader Team leader Responsible for Computer System Validation SAP IT Projects Pharmaceutical Process Validation Business Process Optimization QA and Validation Responsible for Roll out of international Projects
Senior Lead Consultant
Altran Consultancy
Jan 2013 - Jan 2016
3 years 1 month
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
Senior Consultant
IDS Scheer
Aug 2012 - May 2013
10 months
Berlin Area, Germany
Responsible for providing consultancy services for Pharmaceutical companies Responsible for providing SAP consultancy services to clients Responsible for GxP compliance and Validation Responsible for Computer System Validation Responsible for Business Development, new customer acquisition and account management
Senior Consultant
IDS Scheer Software AG
Aug 2012 - May 2013
10 months
Berlin Area, Germany
Responsible for providing consultancy services for Pharmaceutical companies Responsible for providing SAP consultancy services to clients Responsible for GxP compliance and Validation Responsible for Computer System Validation Responsible for Business Development, new customer acquisition and account management
Consultant
IDS Scheer Consultancy, Germany
Jan 2012 - Jan 2013
1 year 1 month
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 optimisation Consultancy services for SAP solutions Planning, implementation and controlling of pharmaceutical production processes Business Development and new customer acquisition
Director, Business Development
Certara
Jun 2011 - Jul 2012
1 year 2 months
Germany, Austria, Switzerland, Israel
•Responsible for identification of new leads and new customer acquisition •Responsible for business development activities of the company •Main contact point for external partners, agencies and clients •Market research
Director of Business Development
LA-SER, clinical study services
Jan 2011 - Jan 2012
1 year 1 month
Responsible for all Business Development, Project proposal development activities of the company in DACH (Germany, Austria, Switzerland)
Output Pharma Services
Jun 2008 - Jul 2011
3 years 2 months
Head of Business Development
Jun 2008 - Jul 2011
3 years 2 months
•Responsible for identification of new leads and new customer acquisition •Responsible for all business development activities of the company •Responsible for all marketing and advertisement activities of the company •Main contact point for all external partners, agencies and clients •Market research •Responsible for development and establishment of new marketing strategies •Responsible for development and establishment of new company strategies and company focus
Head of Business Development
Jun 2008 - Jul 2011
3 years 2 months
•Responsible for identification of new leads and new customer acquisition •Responsible for all business development activities of the company •Responsible for all marketing and advertisement activities of the company •Main contact point for all external partners, agencies and clients •Market research •Responsible for development and establishment of new marketing strategies •Responsible for development and establishment of new company strategies and company focus
Education
Oxford University
M. Phil., Biochemistry and Molecular Biology
1996 - 1999
3 years 1 month
Bar-Ilan University
B.Sc., Biochemistry and Molecular Biology
1991 - 1995
4 years 2 months