Digital Health & Smart Manufacturing, Quality & Regulatory Expert, Software Validation CSV, IT & Cyber Security
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- Weltweit
- de | en
- 10.03.2024
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
2/2023 – offen
Tätigkeitsbeschreibung
• Large holistic transformation and change program in which different system landscapes (SAP, ERP, Salesforce from different countries) are to be unified (considering local regulations)
• The project is in the area of IPG (Integrated Package Gas) and Supply Chain.
• Create target/actual analysis of the above-mentioned system landscapes (participation in workshops, documentation, develop strategies, sell ideas).
• Independent negotiations with department heads and other management levels for the possible implementation of topics in the Integrated Package Gas area
• Independent definition of IT-technical components and requirements
• Advice on compliance with the implementation and deadlines for topics arising from the target/actual analysis.
• Run Digital Risk Assessment and Digital Projects regarding IT Security & Cyber security, GDPR and business risk arising from Digital Solutions
• Advising staff on the relevant work tasks and processes and change management
Cloud (allg.)
10/2022 – 6/2023
Tätigkeitsbeschreibung
- Creation of URS document for DHP including Regulatory & quality requirements/controls, SLCM & validation requirements, Data protection & security requirements
- Creation of Architecture Handbook for DHP (build on Cloud Computing/Xaas)
- Manage and coordinate DHP Design Workshop
- Lead and coordinate Supplier Selection process for DHP/ Cloud Services, pre-selection of suitable suppliers based on created supplier questionnaire,
- Audit Supplier regarding ISO 13485 and IEC 62304 as well as IT & Cyber Security (Cloud Security Alliance) and System Lifecycle processes (BSI Compendium, ISO 27001)
- Run Supplier Demos and perform Gap Assessment with recommendations for contract negotiation
Cloud (allg.)
3/2022 – offen
Tätigkeitsbeschreibung
• 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
Tätigkeitsbeschreibung
• 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
Tätigkeitsbeschreibung
• 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
Tätigkeitsbeschreibung
• 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
Tätigkeitsbeschreibung
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 Entwicklung, Auditor, Biotechnologie, Business Analyse, Cloud Computing, DIN EN ISO 13485, DIN ISO/IEC 27001, ITIL, Medizintechnik / Labortechnik, Pharma / Kosmetik, Projektleitung / Teamleitung, Qualitätsmanagement / QS / QA (IT), Requirement Analyse
12/2021 – 11/2022
Tätigkeitsbeschreibung
• 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
Tätigkeitsbeschreibung
• 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
Tätigkeitsbeschreibung
• 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.)
Ausbildung
Riedlingen
Krems
Über mich
She accompanies medical technology start-ups and SMEs in the development and introduction of digital product innovations. For this purpose, she has designed her own regulatory roadmap from her years of experience in the pharmaceutical industry, biotechnology and medical technology, which promises a product launch within 12 months. This "fast track" begins with the generation of ideas, through the establishment of a quality management system and technical documentation, to the market launch. It also includes building a digital integrated ecosystem with cutting-edge technologies.
She also has more than 18 years of experience in global corporate roles and multicultural and multidisciplinary IT and business transformation projects and programs with extensive expertise and professional experience in regulated environments. In doing so, she leads nearshore and offshore teams in multiple locations.
She is known as an Excellent Writer, Presenter and Facilitator for global projects with large audiences, customer focused, always motivated to exceed expectations and go the extra mile.
Weitere Kenntnisse
• IT Security Officer & Auditor for ISO 27001 (TÜV), Cyber Security ISACA/ BSI
• Business Analyst & Requirements Engineer (IREB, UX, Human Centered Design)
• IT Quality & Regulatory Compliance Auditor (GxP, EMA, FDA)
• Quality Management System Expert (Pharmaceutical, Biotechnology, Medical Devices, Healthcare)
• Computer System Validation & Software Verification Specialist (Digital Health Solutions)
• SaFe Scrum Master, Coach & Organizational Change Manager (ZHAW IAP)
More than 18 years’ experience in global corporate positions and multi-cultural and multi-disciplinary IT & Business Transformation projects and programs with extensive know-how and working experience in the regulated Life Science and Health Sector Experience in managing near-shore and / or off-shore teams across multiple locations
• Excellent writer, presenter, moderator and facilitator for global projects with large audience
• Customer focused, motivation to exceed expectations and go the extra mile
• Consulting Services:
o Digital Transformation in Healthcare & Life Science, Digitalization of business processes and modern IT architecture, Digital Health & Smart Manufacturing
o Regulatory Compliance and Audits within Pharmaceuticals and Medical Device industry (GxP, EMA, FDA, PIC/S, ISO, MDR, ICH)
o Quality Management and Assurance for Software Development of Digital Health Solutions, Medical Device Software, Software as a Medical Device and Computerized Systems (ISO 13485, FDA 820)
o Software Validation and Verification (IEC 62304/ 82304, GAMP 5/ CSV)
o Electronic Records & Signatures/ ERES (Annex 11, Part 11)
o Data Integrity
o Quality & Product Risk Management (FMEA, ISO 14971)
o Information & Cyber Security Management ISO 27001 TÜV SÜD certified Compliance Officer, ISACA/BSI certified Cyber Security Practioner
o Business Analysis and Requirements Engineering (BABOK, IREB)
o Usability & User Experience, Human-Centered Design (UXQB, IEC 62366)
o Business Process Modeling & Transformation, BPMN 2.0
o Digital and Mobile Solutions Development, Cloud Solutions, Data Repository, Digital Health Platforms (IoT), Agile/Scrum, Design Thinking, Smart Manufacturing SAP and MES (Manufacturing Execution System)
o Systemic Organizational Development, Change and Communication Management
o Business Coaching (St. Galler Management Model, Systemic, Hypnotherapy, Introvision etc.)
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Europäische Union
- Schweiz
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