freiberufler Digital Health & Smart Manufacturing, Quality & Regulatory Expert, Software Validation CSV, IT & Cyber Security auf freelance.de

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

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  • 4132 Muttenz
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  • de  |  en
  • 10.03.2024

Kurzvorstellung

Digital Transformation in Healthcare & Life Science, Quality Assurance, Regulatory Compliance, Audits within Pharmaceuticals and Medical Device industry, CSV Computer Software Validation, Agile Methods (IEC 62304/82304, GAMP 5), SAP & MES

Qualifikationen

  • Agile Entwicklung
  • Auditor
  • Biotechnologie
  • Business Analyse
  • Cloud (allg.)
  • Cloud Computing
  • DIN EN ISO 13485
  • DIN ISO/IEC 27001
  • ITIL
  • Manufacturing execution system (MES)
  • Medizintechnik / Labortechnik
  • Pharma / Kosmetik
  • Projektleitung / Teamleitung
  • Qualitätsmanagement / QS / QA (IT)
  • Requirement Analyse
  • SAP S/4HANA

Projekt‐ & Berufserfahrung

IT Business Partner SCM for IT Digital Transformation
Air Liquide GmbH, Düsseldorf and worldwide
2/2023 – offen (1 Jahr, 3 Monate)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Cloud (allg.)

Strategy Consultant & Project Lead – Digital Transformation
Möller Medical, Fulda
10/2022 – 6/2023 (9 Monate)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Cloud (allg.)

CSV/ Quality & Compliance Strategy Consultant for Artwork Management
Beiersdorf AG, Hamburg and worldwide
3/2022 – offen (2 Jahre, 2 Monate)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Cloud (allg.)

TECH Senior Cyber Risk Consultant for Cloud Transformation Program
Telefónica, Germany
2/2022 – 12/2022 (11 Monate)
Telekommunikation
Tätigkeitszeitraum

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.

Eingesetzte Qualifikationen

Cloud (allg.)

Senior Project Manager & Specialist Digitalization new iNeST Manufacturing Facility (Next Generation Immunotherapy)
BioNTech, Mainz
2/2022 – 12/2022 (11 Monate)
Life Sciences
Tätigkeitszeitraum

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.)

Eingesetzte Qualifikationen

Cloud (allg.)

CSV/ Quality & Compliance Strategy Consultant for Digital Manufacturing (MES)
Beiersdorf AG, Hamburg and worldwide
1/2022 – offen (2 Jahre, 4 Monate)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Cloud (allg.)

Quality & Compliance Strategy Consultant for Digital Health Innovations
Kundenname anonymisiert, Diverse
1/2022 – offen (2 Jahre, 4 Monate)
Life Sciences
Tätigkeitszeitraum

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.)

Eingesetzte Qualifikationen

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

Strategy Consultant for Digital Health App & SaMD
EKF Diagnostics, Barleben
12/2021 – 11/2022 (1 Jahr)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Cloud (allg.)

Quality & Compliance Strategy Consultant for Cloud Transformation Program with focus on CSV & IT Security Strategy
Beiersdorf AG, Hambrug
5/2021 – 12/2022 (1 Jahr, 8 Monate)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Cloud (allg.)

Quality & Compliance Strategy Consultant for Cloud CSV & IT Security Strategy (Azure, SAP, RIMS)
Nordmark Pharma, Hamburg
3/2021 – 7/2021 (5 Monate)
Life Sciences
Tätigkeitszeitraum

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

Eingesetzte Qualifikationen

Cloud (allg.)

Ausbildung

Clinical & Health Psychology
Bachelor of Science
2023
Riedlingen
Information Technology within Healthcare
Master of Science
2021
Krems

Über mich

T.'s heart has been beating for lean and effective quality management in the medical technology, biotechnology and pharmaceutical industry for over 15 years. She is passionate about new technologies for digital transformation in healthcare, from Digital Health Platforms to Health Apps/ Software as a Medical Device to GxP compliant computer systems for business process automation.

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

• Master of Science in Information Technology in Healthcare
• 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

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
bevorzugt
Profilaufrufe
905
Alter
46
Berufserfahrung
24 Jahre und 10 Monate (seit 06/1999)
Projektleitung
10 Jahre

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