Good Manufacturing Practice Expert

• 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; 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; 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, handed over on schedule

• 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

• Designed an open clinical framework for digitalization in pharma and clinical software development.
• Developed a minimum viable product (MVP) for the framework, applying agile methodologies and rapid prototyping best practices while ensuring GxP validation and HIPAA compliance.

• 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.

Built and drove the implementation of an ISO 13485-aligned quality management system for a newly established medical-device manufacturer developing products for leading OEM customers. Led RA/QA strategy, QMS architecture, design-control setup, supplier-...

• Support for one of the largest logistics service providers in handling ServiceNow tickets in the areas of SAP MDG, Business Partner (BP), customer and supplier master data
• Technical analysis and resolution of tickets through in-depth review of various database tables
• Creation and maintenance of accounting clerks in the system
• Deactivation of company codes using transports
• Carrying out mass changes with LSMW (Legacy System Migration Workbench)