Project Manager Digitalization

20+ years of experience in digital transformation, MES & EBR implementation with a focus on EU & FDA compliance

Successfully led cross-functional teams to implement scalable IT solutions in Pharma & MedTech

Expertise in project & change management, workshop facilitation and integration of digital solutions into SOPs

Specialist in aligning digital systems with regulatory requirements to optimize processes & ensure compliance

Facilitate workshops & develop negotiation strategies

Lead internal coordination to find solutions

Experience with relevant EU regulatory requirements, FDA, and pharmaceutical regulations

Advise on internal validation processes

Adapt existing SOPs to digital requirements

Develop and implement new standard processes and documentation standards

Analyze regulatory minimum requirements for sterile drug manufacturing documentation

Define internal digital implementation steps

Identify potential cost-saving opportunities

Revived & led the global CTMS implementation project, ensuring structured project governance and stakeholder alignment

Conducted comprehensive demand, requirements, and gap analysis to align system capabilities with Biotronik’s operational needs

Successfully identified and assessed new vendor options, ensuring compliance with clinical trial and MedTech industry standards

Evaluated cost-saving alternatives, including the possibility of consolidating EDC, eMVR, CTMS, iMedNet, Salesforce, SuccessFactors, HDCM, EAC, CVT, and eTMF into a unified solution

Developed an integration strategy and roadmap for seamless interoperability with existing IT infrastructure

Managed the decommissioning of legacy systems, ensuring a smooth transition to the new CTMS platform

Established global support structures, vendor SLAs, and internal OLAs to ensure long-term system stability

Conducted training and change management assessments, fostering adoption across international teams

Led MES implementation and digitalization of batch records (MBR design and execution) to align with regulatory requirements (ISO 13485, FDA, GxP)

Defined digital workflows, system validation strategies, and data integrity requirements for seamless MES integration

Developed standardized electronic batch documentation (EBR), ensuring compliance, traceability, and operational efficiency

Successfully relocated critical production machinery while ensuring minimal downtime and operational stability

Developed negotiation concept

Designed and implemented production workflows, digital process tracking, and automated reporting systems

Managed capacity planning, material flow adjustments, and MES reconfiguration to align with new production sites

Developed new SOPs and digital documentation standards for MES-driven manufacturing

Ensured alignment with GxP, FDA, and EU regulatory frameworks, integrating LIMS, QMS, and automated data capture solutions

Led cross-functional teams and stakeholder negotiations to harmonize global production standards across multiple client´s sites

Digitalized an analog manufacturing system for clinical research, focusing on batch record automation and compliance

Implemented MES, LIMS, SAP, eSignature, Label Management, and Quality Control integration to support personalized medicine and vaccine production (sterile drug production)

Led batch scale-up optimization, increasing production efficiency to 8,000 vials per batch

Developed automation and RPA solutions to standardize production data collection, analysis, and regulatory reporting

Ensured full regulatory compliance with GxP, ISO 14155, TCI 184, and pharma manufacturing standards

Led MES/PAS-X implementation for digital batch records in a highly regulated pharmaceutical environment

Integrated electronic batch records (EBR), SAP records, and MBR designs to streamline production workflows

Managed interfaces to vaccine production, ensuring compliance with FDA, GxP, and GMP standards (sterile drug production)

Coordinated automation initiatives, including packaging robotics, self-driving vehicles, and digital water dosing concepts

Risk management and validation to ensure smooth digital transitions and regulatory approval

Moderation of different stakeholders

Creation of negotiation concepts