Digital Health & Smart Manufacturing, Quality & Regulatory Expert, Software Validation CSV, IT & Cyber Security

3/2022 – offen

• Global Rollout of Artwork Management D2P IT system used for cosmetics, OTC and medical products worldwide
• Establish Global Validation Strategy for Core system
• Creation of Validation Master Plan incl. CSV Templates for Validation Plan & Report, Supplier Audit, Risk Management (based on new GAMP 5 2nd edition, FDA CSA and Agile methods)
• Accompany and perform Validation activities and documentation.
• Conduct IT Supplier Audits, Validation of Azure Devops from IT supplier for SLCM

Cloud (allg.)

2/2022 – 12/2022

• Plan, coordinate and control the software development within RAITT to check that all software packages have the needed compliance requirements implemented:
• Definition of low-level security design
• Implementing of the new Security, Compliance, Risk and Data Protection controls
• Independent coordination of technical units within the scope of analysis and implementation of the above-mentioned new functionalities
• Create a low-level specification document for new controls to be developed within RAITT
• Project management for software development monitoring that the controls mentioned above are implemented correctly.

Cloud (allg.)

2/2022 – 12/2022

• Develop, establish and drive MES Core Strategy and rollout concept for manufacturing sites (Release & Change Management, Requirement Management within Azure Devops, Validation Strategy)
• Lead Fit/Gap Workshops and support BNT Experts in defining/ prioritizing potential software gaps
• Manage delivery of 5 MBR blueprints according to process specification for review & test for Pilot Facility. (MBRs, GMBRs, ESP, Master data)
• Consult MBR specification creation, Consult Label design and configuration in PAS-X for ca. 10 labels according to specification.
• Establish continuous improvement of MBR Design following process & interface clarification.
• Consult completion of qualified installation of system environment
• Build and enroll Project Governance Model
• Lead Project Management (Project Plan, Risks, Budget, Resources)
• Facilitate and engage stakeholders from PM, IT, QA, CSV and Business
• Design, coordinate and moderate Workshops for MES System Implementation (Fit-Gap-Analysis, Blueprint Design, Verification Strategy etc.)

Cloud (allg.)

1/2022 – offen

• Global Rollout of MES to all local production sites (Pilot Sites: Poland, Brazil, Mexico, Thailand)
• Establish Global and local Validation Strategy for Core MES (Traksys & Promas plus Interfaces to Movement Controller, LIMS, Siemens S7 etc.)
• Creation of Validation Master Plan incl. CSV Templates for Validation Plan & Report, Supplier Audit, Risk Management (based on new GAMP 5 2nd edition, FDA CSA and Agile methods)
• Accompany and perform Validation activities and documentation, run CSV MVPs in local sites and update of Local Validation Strategy and Templates
• Conduct IT Supplier Audits
• Manage Retro & Lessons Learned Workshop with all regulated production sites

Cloud (allg.)

1/2022 – offen

Quality & Compliance Strategy Consultant for Digital Health Innovations
• Combination products (BioTech/MedTech)
• Software as a Medical Device, Digital Health Apps, Digital Thearpeutics
• Exoskeleton, Software Apps and Digital Health Platforms
• Health Information Platforms for RWD, Genetic/DNA data, R&D

Service Delivery and direct report to CEOs, CIOs, Global Quality & Regulatory Heads
• Audit and Assessment of regulatory landscape for Product Classification and Development, define scope technical documentation to achieve conformity
• Encourage and develop V&V strategy for Product Development 62304/82304 and achieve CE Mark or market access (EU/US)
• Concept & Design of QMS (Biotech, MedTech) and achieve certification (EMA, FDA, Notified Body)
• Build Cloud & Data Repository Strategy for Digital Health Platform as part of Medical Device or SaMD
• Build IT Operating Model (ITIL, IT4IT, SaFe DevOPs, Scrum) including Computer System Validation GAMP 5, Annex 11, Part 11, IT & Cyber Security ISO 27001, BSI, ISACA,
• Implement Supplier Management & Governance Model
• Design, coordinate and moderate Workshops – onsite and remote, using interactive digital presentations and moderation tools (Teams, Zoom, Webex, MIRO, MURAL, Mentimeter,Asana, JIRA, Confluence etc.)

Agile Methodologie, Auditor, Biotechnologie, Business Analysis, Cloud Computing, DIN EN ISO 13485, ISO / IEC 27001, ITIL, Medizintechnik, Pharma / Kosmetik, Projektleitung / Teamleitung, Qualitätsmanagement / QS / QA (IT), Requirement Analyse

12/2021 – 11/2022

• New Product Release of POC data management system EKF Link
• IVDR Update
• Concept SLCM with Supplier
• Update QMS 13485 with IEC 62304/82304

Cloud (allg.)

5/2021 – 12/2022

• Improvement and update of BSS/BDF Validation Strategy Incl. CSV Policy, Templates for Validation Plan & Report, Supplier Management, Risk Management (based on new GAMP 5 2nd edition and FDA CSA)
• Encourage and develop global Strategy for Qualification and Validation of Cloud Solutions (Iaas, Paas, SaaS, Kubernetes) used for medicinal and GxP-relevant data
• Transition from on premise to Cloud Strategy (Azure, SAP 4HANA)
• Scope: Computer System Validation GAMP 5, Annex 11, Part 11, IT & Cyber Security ISO 27001, BSI, ISACA
• Conception Validation Strategy Incl. Policy, Templates for Validation Plan & Report, Supplier Management, Risk Management

Cloud (allg.)

3/2021 – 7/2021

• Encourage and develop global Strategy for Qualification and Validation of Cloud Solutions (Iaas, Paas, SaaS, Kubernetes) used for medicinal and GxP-relevant data
• Scope: Computer System Validation GAMP 5, Annex 11, Part 11, IT & Cyber Security ISO 27001, BSI, ISACA
• Conception Validation Strategy incl. Policy, Templates for Validation Plan & Report, Supplier Management, Risk Management

Cloud (allg.)