Christof Layher
Driving digitalization in life sciences forward - without chaos, without excuses, but with structure.
Experience
GxP Digitalization Problem Solver
CHAOSHACKER
- Acting as an external sparring partner, organizer, and implementer for mid-sized life science and MedTech companies on key digital topics.
- Focus on quick analysis, clear decisions, and concrete progress instead of long strategy papers.
- Clarifying IT complexity, responsibilities, and compliance risks.
- Developing pragmatic digitalization strategies (including under GxP).
- Conducting quick checks, IT roadmaps, and vendor analyses.
- Supporting projects in cloud migration, system selection, and audit preparation.
- Assisting management with digitalization decisions.
Director Validation Digital Systems
BioNTech SE
- Strategic lead of IT validation and development of agile validation models for single systems and multi-system architectures.
- Building and leading a 50-member team, including Corporate IT Quality and Compliance units.
- Introducing flexible resource management for complex projects under high time pressure.
- Close collaboration with QA and regulatory authorities to ensure compliance and continuous process optimization.
- Promoting employees through innovative training programs and collaborative development approaches.
- Fostering an agile work culture to increase productivity and team autonomy.
- Working closely with IT architects and business stakeholders to design platform strategies securely and efficiently.
- Implementing proactive compliance strategies as enablers for digital business processes.
- Supporting the successful first production at the Mainz site with full CSV coverage up to auditing.
- Optimizing documentation requirements, reducing effort by 60%.
- Establishing hybrid work models with sustainable productivity gains.
System Architect
BioNTech SE
- Designing and planning innovative IT architectures for biotech solutions.
Podcast-Host
CHAOSHACKER-TALK
- Initiating and hosting a podcast format on topics like digital transformation, leadership, agile methods, and technological advances in the pharma and biotech industry.
- Creating editorial content and recruiting leading experts for practical discussions.
- Introducing interactive formats like live discussions and Q&A sessions to boost listener engagement.
- Strategically planning and executing marketing and community-building activities.
- Publishing over 28 episodes with leading experts and practical insights.
- Building a community with early regular listeners and growing social media interaction focused on sustainable growth and active engagement.
Managing Director & Owner
O.O.C.A GmbH & ICATO E.K.
- Strategically leading and implementing IT architecture and digitalization projects focused on scalable platform solutions, process automation, and digital transformation.
- Developing and implementing agile IT strategies for the efficient rollout of new systems and optimization of existing IT landscapes.
- Collaborating closely with companies to translate technological innovations into secure and economically sustainable business processes.
- Designing and scaling digital platforms to optimize business workflows and IT architectures.
- Advising and executing over 35 digitalization projects, including ERP and DMS integrations, cloud migrations, and process automation.
- Introducing and refining agile methods to boost efficiency and IT governance.
- Building technology partnerships to support groundbreaking pilot projects in cloud, AI, and compliance-driven IT platforms.
Technical Consultant
Various IT service providers
- Implementation of innovative IT solutions and consulting on technical challenges.
Group leader
Bundeswehr
- Leadership during deployments and development of a high-performing team.
Summary
IT executive with a focus on the strategic optimization of digital platforms and IT architectures for highly regulated environments. Specialized in ensuring a compliant and efficient operation of IT platforms that serve as enablers for business processes. Many years of experience in IT compliance, digital transformation, and strategic scaling of IT teams. Proven success in leading interdisciplinary teams and strategically realigning complex IT processes. Deep expertise in implementing agile methods and introducing resource-saving models to boost efficiency. Inspiring leader with a passion for technical excellence and digital transformation in the life science sector.
Since 2025, also serving as a consultant for mid-sized company CEOs seeking guidance in digitalization and AI.
Skills
It System Integration And Automation
Resource Management And Team Leadership
Change Management
Strategic Scaling Of It Teams
It Architecture And System Validation
Digitalization In The Life Science Sector
Gxp Compliance And Quality Management
Technical Process Innovation
Agile Methods And Process Optimization
Audit Preparation And Regulatory Compliance
Clarifying It Complexity, Responsibilities, And Compliance Risks
Developing Pragmatic Digitalization Strategies (Including Under Gxp)
Conducting Quick Checks, It Roadmaps, And Vendor Analyses
Project Support For Cloud Migration, System Selection, Audit Preparation
Supporting Management In Digitalization Decisions
Microsoft Office
Sap
Jira
Miro
Dms Software
Git
Azure
Aws
Cloud
Python
C#
Html/css
Sql
Strategic Scaling Of It Platforms & Business Enablement
It Governance & Compliance As Enablers For Digital Processes
Change Management & Transformation Of It Systems
Agile Leadership & Coaching Of International Teams
Languages
Certifications & licenses
CS50's Introduction to Computer Science
edX
ITIL® V4 Foundation
Com-Training
Certified SAFe 5 Agilist
Scaled Agile, Inc.
Delivering Quality Work With Agility
IBM Skills Network
Counterintuitive Leadership Strategies For A VUCA Environment
NASBA
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