Good Manufacturing Practice Experts in Germany

• Development and implementation of customized information security strategies

• Introduction and further development of ISMS according to ISO 27001, BSI-Grundschutz and other standards

• Risk management and preparation of security concepts

• Consulting for KRITIS, PCI DSS, TISAX and VdS 3473/10000

• Establishment and optimization of security organizations

• Creation and implementation of policies, guidelines, work instructions and process descriptions

• Audit support and certification preparation

• Delivery of training sessions, workshops and awareness campaigns

• Selection and consulting for the introduction of IT security solutions such as SIEM, DLP, IDS/IPS, firewalls and encryption technologies

• Conducting penetration tests and vulnerability analyses

• Consulting on the selection, integration and management of security architectures in complex IT environments

• Consulting on ITSM, managed security services and SOC

• Management and coordination of complex projects to improve information security

• Process analysis, optimization and management according to ITIL, ISO 27001 and cybernetics

• Introduction and quality assurance of management, documentation and knowledge management systems

• Support in complying with regulatory information security requirements (e.g. GDPR, HIPAA, SOX, GMP, KRITIS)

• Development and implementation of risk analysis procedures

• Organization of initial response, forensic investigations and organizational measures in security incidents

• Design and delivery of targeted workshops on topics such as ISMS, IT risks and current threat scenarios

• Awareness campaigns to promote a security culture in companies

• Special training on ISO 27001, BSI-Grundschutz, KRITIS and other relevant standards

• Simulations and exercises to prepare for information security incidents

• Interim management for leading information security projects or IT security organizations

• Taking on the role of external CISO (Chief Information Security Officer)

• Support in developing and implementing IT security and corporate strategies

• Coaching and mentoring of managers in information security

• Establishment and management of security departments, including employee recruitment and qualification

• Temporary assumption of management responsibility in critical situations

AI Readiness - Part 3: Creating an e-book on the use of AI in software testing

• Designed and created an e-book on the sensible and safe use of AI in software testing from the perspective of an experienced test expert.
• Used generative AI (ChatGPT, Perplexity Pro) as a sparring partner for structuring, wording suggestions and creating variations, with all content finally reviewed and approved using my own expertise.
• Developed practical insights into the opportunities and risks of AI in testing, with a special focus on collaboration between testers and AI instead of “tester vs. AI”.
• Title: “11 starke Gründe: Dream-Team statt Rivalen - Tester und KI sind gemeinsam unschlagbar”
• Subtitle: “Wie Mensch und Maschine im Softwaretest das perfekte Team bilden – und warum reines KI-Testing riskant ist.”
• Planned use of the e-book as a basis for workshops, customer meetings or internal training.
• Technology: Generative AI, ChatGPT, Perplexity Pro, Microsoft Word, Adobe Acrobat, many years of hands-on professional testing experience, common sense.

• Electronics – Surface Solutions | Carve-out of IT, data and system landscape*

• Separation of a full business division's IT, data and system landscape following divestment across cloud, on-premises and connected laboratory systems; centrally governed investment envelope in the three-digit m€ range

• Laboratory notebook and laboratory analytics platform stream: Palantir Foundry, Snowflake, Signals Notebook, Power BI and connected laboratory instrumentation; SharePoint and JIRA; site transition completed without interruption to laboratory operations

• Decision authority and escalation point for business, IT infrastructure, IT security and vendors; separation executed across globally distributed users and systems and handed over on schedule, avoiding a contractual penalty for the client

• Project: ESU Windows and SQL Server Consolidation / Configuration Management in ServiceNow
• Prepared an as-is analysis of all servers worldwide
• Prepared an as-is analysis of all SQL servers worldwide
• Conducted requirements analyses for SQL and server migrations
• Coordinated requirements with partners for migrations to Hyper-V (on-premises) or Azure Cloud
• Facilitated regular status meetings (Jour Fixe)
• Developed roadmaps and solution models for server migrations
• Set up test scenarios
• Facilitated workshops for the rollout of a global admin team
• Designed data models (CMDB) in ServiceNow
• Led workshops for the CMDB data model
• Developed solution models for the CMDB
• Created end-to-end configuration documentation and work instructions for the CMDB
• Prepared reports for license management
• Defined KPIs for data quality in ServiceNow
• Created a service catalog
• Facilitated workshops to define service requests
• Acted as interface between requirements analysis and the ServiceNow development team
• Systems used: Windows 7, Windows 10, Microsoft Office 365/2010, Windows Server 20xx, SQL Server 20xx, SharePoint, Azure Cloud, Hyper-V, ServiceNow, various tools

• Head of department overseeing laboratory operations, ensuring efficient, compliant, and inspection-ready processes across BSL-2 and BSL-3 areas
• EHS site lead and biosafety officer for BSL-2 and BSL-3 laboratories (conventional and GMO), ensuring adherence to biosafety, biosecurity, and regulatory requirements
• Primary point of contact with local authorities, responsible for regulatory submissions and approvals for BSL-2/BSL-3 operations, including GMO registration (S2/S3)
• Risk management activities, including risk assessments, mitigation strategies, and continuous monitoring to ensure safe and compliant operations
• Successfully led the organization through ISO 14001 (Environmental Management) and ISO 45001 (Occupational Health & Safety) certifications, embedding sustainable and safe operational practices across the site
• Lifecycle management of laboratory equipment and facilities, including strategic planning, acquisition, qualification, validation, and maintenance oversight

• Designed and moderated a NIS2 preparation workshop for RAS Reinhardt Maschinenbau GmbH and its IT service provider Catuno GmbH. Together with executive management and IT leadership, the current status was assessed, an initial GAP analysis was conducted and areas for action were prioritized based on ISO 27001.
• Developed an ISO-27001-based regulatory framework (ISMS) for NIS2 compliance, including a structured current/target GAP analysis, targeted improvement of the security maturity level and preparation of the organization for NIS2 audit readiness.

• Worked for several M&A projects (Eire, Sunshine C, Coral) in the role of IT project manager and cross-functional technical manager / integration manager.
• Preparation and maintenance of project charters, project change requests and project plans.
• Weekly project status report.
• Preparation of decision papers and steering committee slidedecks.
• Risk & issue management.
• Tracking and managing activities, dependencies and deliverables across all functional IT domains.
• Data migration (planning and execution).

• Senior agile practitioner in a complex, regulated pharmaceutical environment — facilitating Scrum ceremonies across three international teams (~40 people) while supporting delivery governance and agile coaching.
• Time-limited assignment to bridge the gap until the client could fill the role internally
• Facilitated all Scrum ceremonies (Sprint Planning, Daily Stand-up, Review, Retrospective) across multiple international teams; kept sprints predictable and productive
• Coached teams and Product Owners in agile practices within a GxP-regulated environment, pragmatically balancing agile ways of working with QMS compliance requirements
• Tracked and visualized delivery metrics, managed dependencies, and produced status reports for senior stakeholders and Steering Committee
• Stepped up to project leadership of the internal CCMS product initiative: introduced structured processes and transparent tooling into a previously low-governance environment
• Actively contributed to the company-wide Agile Community of Practice, including authoring blog articles on agile topics
• Commended for analytical thinking, reliability under pressure, and the ability to manage multiple workstreams simultaneously

• Quality assurance and management of bioanalytical study data in LIMS and ELN systems
• Ensuring compliance with GLP and GCP in clinical studies
• Supporting project teams with quality- and compliance-related questions
• Quality assurance and compliance with regulatory requirements
• Assessment of data integrity, traceability, and study processes
• Close collaboration with QA, laboratory, and study teams in the pharmaceutical environment
• Qualification and validation of various devices (e.g. air samplers, data loggers, freezers, refrigerators, incubators)
• Maintenance and calibration of various devices (e.g. air samplers, data loggers, sensors)
• Deviation management (Deviations)
• Qualification and maintenance of monitoring systems (sensors for pressure, temperature, room temperature, and humidity), including alarm systems
• Execution of qualification and validation activities: CC, CQ, IQ, OQ, PQ, RA, CR, CAPA, DQ
• Preparation and review of URS, RTM, test plans, and qualification documentation
• Checking, maintaining, and tracking quality-related documentation

• Workflow automation
• Process management
• Scrum Master
• Introduction of new office processes at regional and global level
• Project assistance in ISO 9001, 13485 and 17025 projects

• Support for the reorganization process of the GMP QA system
• Review, adaptation and restructuring of the PQR process and documentation
• Review, adaptation and restructuring of the GMP warehousing process and documentation
• Support / consulting on GMP processes (deviations / complaints / others)
• Review, adaptation and restructuring of GMP and GDP interfaces / processes

• Interim leadership responsibility for realigning the entire leadership organization – away from classic target setting and solution specification toward a teal-oriented organization with clear responsibility for each individual employee.
• Stabilization of production processes and reduction of the backlog in all customer projects.
• Building up the necessary material inventory (agreed with end customers by contract) – eliminated backlogs and special runs, achieved 2 weeks of material inventory.
• From the start of the assignment, also took over overall technical responsibility for Research & Development (R&D).
• In addition to the CSO/COO role, took over responsibility for controlling and finance in the last 9 months.

• Optimization of business results and expansion of sales activities
• Responsible for personnel organization
• Introduction of a document management system (DMS)
• Introduction and optimization of the ERP, CMS and CRM landscape
• Introduction of digital signatures
• Increase in revenue, reduction in costs and increase in EBIT

• Led end-to-end delivery of complex international customer-facing IT and system transformation projects across mobility, retail, life sciences, and product development domains.

• Managed project opportunities and delivery initiatives from concept development, planning, execution, migration, validation, deployment, and final customer acceptance.

• Acted as the primary point of contact for project stakeholders, ensuring alignment between customers, business units, suppliers, and delivery teams.

• Ensured timely project execution through proactive monitoring of milestones, deliverables, dependencies, risks, and resource requirements.

• Led and coordinated global cross-functional teams of 20+ members across multiple time zones. Served as the central coordination point for project activities, ensuring accountability, milestones, progress tracking, and timely resolution of issues across multiple stakeholders. Managed status reporting with all the stakeholders, providing clear and timely updates to ensure alignment on project goals.

• Provided functional leadership, mentoring, coaching, and issue resolution support to project team members. Worked closely with senior leadership and executive stakeholders to define project charter and project scope, priorities, milestones, manage dependencies, success criteria and achieve project goals.

• Collaborated closely with senior leadership, business stakeholders, suppliers, operations teams, and external partners to define project objectives and ensure successful execution.

• Managed stakeholder communication through executive dashboards, KPIs, governance reviews, steering committee meetings, and project status reporting.

• Anticipated business needs and provided effective technical solutions in a timely manner to improve business satisfaction.

• Led and supported sub-project management structures, ensuring consistent execution, reporting, and escalation across complex initiatives.

• Managed supplier relationships and service providers to ensure compliance with contractual obligations, service levels, timelines, and quality expectations.

• Supported vendor selection processes, RFP evaluations, delivery governance, cost monitoring, and performance reviews.

• Controlled project budgets, forecasts, resource allocations, and financial tracking to ensure delivery within approved constraints.

• Scheduled workshops explaining the business requirement, prioritizing project goals and managing change.

• Oversaw cloud migrations (Azure/ AWS), database migrations/upgrades, system upgrades, infrastructure & application modernization, data management, legacy decommissioning initiatives, AI solutioning, transition plan of 2000+ applications etc.

• Coordinated execution, deployment, integration, commissioning, data migration and handover activities to ensure production readiness.

• Led a cross-functional team proactively managing dependencies and resolving project issues to closure, while maintaining delivery timelines.

• Proactively managed project risks, dependencies, issues, change requests, and escalations to ensure predictable project outcomes.

• Ensured compliance with GxP, ITIL, corporate governance standards, validation requirements, and audit controls.

• Led internal and external audit support activities, validation documentation, CAPA coordination, and regulatory compliance initiatives.

• Drove process standardization, automation, and governance improvements across project delivery functions.

• Led application rationalization initiatives resulting in the retirement of more than 50 legacy applications, improving operational efficiency and reducing maintenance costs.

• Currently driving Generative AI initiatives to automate project documentation, reporting, knowledge management, and delivery processes.

• Facilitated lessons learned workshops and implemented continuous improvement actions to enhance project execution effectiveness.