Fabian Schnell - Project Manager and Quality Specialist

Mannheim, Germany

Experience

Jan 2025 - Dec 2025

1 year

Bad Ems, Germany

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

Apr 2024 - Sep 2024

6 months

Waghäusel, Germany

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

Aug 2022 - Dec 2023

1 year 5 months

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

May 2022 - Sep 2024

2 years 5 months

Bergkamen, Germany

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

Apr 2022 - Oct 2022

7 months

Leverkusen, Germany

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

Feb 2022 - Apr 2022

3 months

Duisburg, Germany

IT Research Engineer

Inconsult

Research in validation automation and AI validation
Developed a POC for automating requirements engineering in the validation toolchain (Polarion/JIRA)

Nov 2021 - May 2022

7 months

Bergisch Gladbach, Germany

Validation Consultant

Miltenyi

Developed an approach for spreadsheet validation
Created a validation protocol including test planning and reporting
Reviewed test execution

Oct 2021 - Mar 2022

6 months

Vestenbergsgreuth, Germany

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

Jun 2021 - Nov 2021

6 months

Karlsruhe, Germany

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

Oct 2018 - Dec 2020

2 years 3 months

Mannheim, Germany

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)

Sep 2015 - Oct 2018

3 years 2 months

Fürth, Germany

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)

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