Fabian (H.) Schnell
Project Manager and Quality Specialist
Experience
Project Manager and Quality Specialist
Uriach Germany GmbH
- iterative implementation of TrackWise Digital as a global eQMS
- project management, stakeholder management, team leadership
- validation of all changes according to GMP/ISO13485 requirements
- development of governance structures in quality and IT
Project Manager
Wirsol Aufdach GmbH
- implementation of Microsoft Dynamics to replace the existing system landscape in a medium-sized company
- coordination of software vendor, product owner and key users
- planning, execution and monitoring of the project plan in coordination with all stakeholders
- analysis and mitigation of project challenges and risks
Organizational Change Management Consultant
Bayer
- supported a LIMS implementation program at 7 sites
- development of change management concepts to scale rollout approaches while ensuring system adoption at the sites
- establishment of an OCM playbook, change stories and best practices
- development and execution of change impact, stakeholder and communication analysis
- surveying stakeholders and deriving action plans for sites based on their needs
Project Manager
Bayer
- implementation of a strategic, cloud-based LIMS at one of two pilot sites (out of 34 worldwide)
- coordination of the local project team (7-8 full-time staff) in a hybrid project setup (sprint-based DevOps, wave-based rollouts), 60-70% remote
- monitoring and managing the project budget of 1.5 million euros
- navigating a political, cross-cultural program structure with various local, global, internal and external stakeholders
- carrying out reporting and communication measures to improve collaboration and team productivity
Validation Consultant
Bayer
- qualification of IT infrastructure systems, services and tools
- qualification of the Data Integration Layer (DIL) for communication between the shop floor and cloud
- qualification of GoodSync for data transfer between infrastructure layers
- qualification of Acronis for backups
IT Research Engineer
Inconsult
- Research in validation automation and AI validation
- Developed a POC for automating requirements engineering in the validation toolchain (Polarion/JIRA)
Validation Consultant
Miltenyi
- Developed an approach for spreadsheet validation
- Created a validation protocol including test planning and reporting
- Reviewed test execution
Lead Validation Consultant
Martin Bauer
- Developed a validation concept for the corporate group according to GMP/GAMP5, CFR Part 11
- Created and implemented the master validation plan
Master's Thesis Student
Schwabe
- Developed a method to support investment decisions for transforming digital landscapes for regulatory affairs, pharmacovigilance, and operations
- Conducted cost analysis of IT systems and potential cost savings
- Applied quantitative data quality analysis techniques
CSV Specialist and IT Quality Manager
Phoenix Pharmahandel
- Validated computer systems in a regulated environment according to Good Distribution Practice (GDP) and GAMP5
- Managed change control as QA for a GAMP5-classified, validated ERP and logistics system
- Maintained lifecycle documentation according to the V-model
- Continuously improved the validation framework and managed QMS documents (e.g., SOP reviews)
Dual Student for Bachelor of Science in Business Informatics
Phoenix Pharmahandel
- Worked in various IT departments of Corporate IT
- Platform and collaboration (SharePoint 2013)
- Development of outbound and inbound logistics software (Java, C)
- Network and security (router configuration, F5 load balancing)
- SAP finance and controlling (SAP FI/CO, data warehousing)
- IT quality management (computer system validation, GxP)
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Pharmaceutical (9 years), Biotechnology (3 years), Energy (0.5 years), Chemical (0.5 years), and Food and Beverage (0.5 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Information Technology (8.5 years), Quality Assurance (4.5 years), Project Management (3.5 years), Finance (3.5 years), and Supply Chain Management (3 years).
Summary
I am a husband, a Christian and a dog dad.
Skills
Industry Knowledge
- It Project And Quality Management (Gxp)
- Manufacturing And Logistics In Regulated Industries
- Quality Control (Laboratory)
Topics
- Project Management, Change Management
- Lateral Leadership, Stakeholder Management
- Business Model And Process Consulting
- Risk-based Quality Management, Validation
Software, Tools And Systems
- Tools: Ms Office + Project, Jira, Confluence, Tfs, Azure Devops
- Software: Trackwise Digital, Sap, Microsoft Dynamics (Crm, Erp), Labvantage Lims
- Bpm: Aris, Symbio, Draw.io, Xmind
- Collaboration: Microsoft Office 365, Sharepoint 2013 / 2016
Languages
Education
Bachelor of Science · Business Informatics
Master of Business Administration, Sales and Consulting · Business Management
Certifications & licenses
Agile Essentials
IPMA Level D
ITIL Foundation
Moderation techniques (e.g. facilitation, design thinking, 5 Whys)
Scrum Basics
Profile
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