ISO 9001 Experts in Berlin

Assignment focus: Leading digital restructuring in a highly regulated Defence and Aerospace environment. Focus areas: improving data flows and data quality, introducing paperless data collection in production, integrating machine data for automatic SPC calculation and process control, as well as cybersecurity analyses.

Main objectives:

• Analyze, structure and improve data flows and data quality in production
• Introduce paperless data collection in manufacturing areas
• Integrate machine data for automatic SPC data calculation and process control
• Implement digital restructuring while meeting regulatory requirements in the Defence environment

Measures and results:

• Analyzed and structured existing production data flows as a basis for control and reporting
• Established mechanisms to ensure data quality and availability across manufacturing areas
• Introduced paperless data collection in production — replacing manual and paper-based processes
• Integrated machine data for automatic SPC data calculation (control charts, Cp/Cpk) and real-time process control
• Conducted cybersecurity analyses in the production and IT environments

Area of responsibility: Project management for digital restructuring, paperless production, data management and data quality in a highly regulated Defence and Aerospace environment.

Support for Transformation Projects:

• Expert CTO advisory and enterprise architecture consulting for several short-term transformation projects, ensuring measurable improvements in project outcomes and technical business alignment.
• Supporting strategic IT initiatives for diverse clients, driving digital transformation and optimizing technology operations to increase business value and operational efficiency.

• Full P&L responsibility (€80M) for multi-site connector production with 150 FTEs.
• Rebuilt operational performance management architecture by introducing the company's first AI-supported KPI system, enabling real-time transparency, executive decision support, and measurable delivery stabilization within 90 days.
• Used the Hoshin Kanri framework to align strategic objectives with daily operations.
• Drove Lean culture and structured Kaizen initiatives across production areas.
• Led manufacturing, production engineering, supply chain, and support functions in alignment with corporate strategy.

• Consulting firm providing interim managers for ERP transformations in mid-sized companies
• Transformation in mid-sized companies (implementation, harmonization, governance)
• Focus: ERP implementation and migration, commercial processes, reporting, implementation control, digitization, business processes, AI interface between executive management, finance, and IT

• Delivered more than 10 clinical trial supply projects, achieving 95% on-time delivery of investigational products in compliance with GCP/ICH guidelines.
• Spearheaded ISO 9001 implementation, conducting 10+ internal audits across HR, Operations, Finance, and Quality, contributing to certification readiness within 12 months.
• Created, updated, and standardized more than 20 SOPs and CAPA processes, reducing documentation errors by 30% and ensuring regulatory compliance.
• Coordinated stakeholders across 6 countries, ensuring proactive risk management, transparent communication, and 100% client satisfaction.
• Leveraged JIRA, SAP, Notion, and CRM tools to optimize workflows and reporting.

• Support the implementation and monitoring of the company’s quality standards to ensure that every product meets the user’s needs and requirements

• Create a dashboard in Excel for monitoring the Cost of Poor Quality which connected data from seven (7) KPIs

• Manage error and issues tracking with JIRA coordinating with engineering and production to conduct root cause analysis and corrective actions

• Collaborate with production and application teams to resolve bugs/issues

• Quickly took over responsibilities after predecessor's departure
• Quickly prepared alternative procurement scenarios with transparent commercial analysis
• Thematically and personally reconnected loose, interdisciplinary threads
• Identified win-win potentials in cooperation with customers

• Operational management of the company: building teams and infrastructure, developing products, analysis and implementation of IT security measures

• Project assignments in the IT security environment focusing on establishing blue teaming activities (defensive processes and technologies) to defend against cyber attacks

• Conducting red teaming processes, including penetration tests and security analyses for companies

• Consulting on setting up Security Operation Centers and implementing SIEM systems, and building Computer Incident Response Teams (CSIRT)

• Auditor for ISO 9001 and ISO 27001, § 8a, ISO 27019, § 11 1a EnWG, TISAX

• Advising companies in critical infrastructures on information security and compliance with the IT Security Act

• Building SIEM/SOC processes and SOC analyst work (Splunk, ELK-Stack)

• Integrating data into monitoring tools (Prometheus, Grafana)

• Consulting on BSI IT baseline protection, ISO 9001, ISO 27001, BCM, ITIL and risk management

• Security assessments and penetration testing of IT and network architectures

• Overall responsibility for IT strategy and IT operations, reporting directly to the executive management.
• Implementation of business requirements as production-ready solutions within a few days, supported by practical data science experience and expertise from the energy sector.
• Led the IT carve-out of a medium-sized company: separation of infrastructure, systems, and contracts into an independent IT organization.
• End-to-end responsibility for IT infrastructure: hardware procurement, cloud services (including GPU resources), and networking.
• Selected and introduced a new ERP system together with the executive management.
• Managed external MSPs and service providers, including contract, SLA, and license management.
• Responsible for IT security, GDPR compliance, backup, and business continuity; provided IT support for ISO 9001 certification.
• IT budget planning and cost optimization.

• Training in Azure technologies & data analysis (Haufe Akademie)
• Technologies: Microsoft Azure

• Carrying out external audits regarding ISO 9001, ISO 27001, ISO 27017, ISO 27018, ISO 22301, WLA-SCS, HDH.

• Company focus: Manufacturing of modular emergency hospital containers
• Administration, finance and controlling
• Build up all processes, procedures, systems and structures in Germany as headquarters
• Post-acquisition integration of a manufacturing plant in Spain
• Setting up a greenfield plant in Serbia
• Reporting line: CEO