freiberufler Digital Health Technology, Quality & Regulatory Expert, Software Validation Scrum SaFe, IT & Cyber Security auf freelance.de

Digital Health Technology, Quality & Regulatory Expert, Software Validation Scrum SaFe, IT & Cyber Security

zuletzt online vor wenigen Stunden
  • auf Anfrage
  • 4123 Allschwil
  • Weltweit
  • de  |  en
  • 01.12.2022

Kurzvorstellung

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

Ich biete

  • Agile Entwicklung
  • Auditor
  • Biotechnologie
  • Business Analyse
  • Cloud Computing
  • Digitalisierung
  • DIN EN ISO 13485
  • DIN EN ISO 27001
  • DIN ISO/IEC 27001
  • ITIL
  • Medizintechnik / Labortechnik
  • Pharma / Kosmetik
  • Projektleitung / Teamleitung
  • Qualitätsmanagement / QS / QA (IT)
  • Requirement Analyse

Projekt‐ & Berufserfahrung

Quality & Compliance Strategy Consultant for Digital Health Innovations
Kundenname anonymisiert, Diverse
1/2022 – offen (1 Jahr)
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

Ausbildung

Clinical & Health Technology

(Bachelor of Science)
Jahr: 2023
Ort: Riedlingen
Information Technology within Healthcare

(Master of Science)
Jahr: 2021
Ort: Krems

Qualifikationen

• 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
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
o Systemic Organizational Development, Change and Communication Management
o Business Coaching (St. Galler Management Model, Systemic, Hypnotherapy, Introvision etc.)

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.

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
Home-Office
bevorzugt
Profilaufrufe
131
Alter
45
Berufserfahrung
23 Jahre und 6 Monate (seit 06/1999)
Projektleitung
10 Jahre

Kontaktdaten

Nur registrierte PREMIUM-Mitglieder von freelance.de können Kontaktdaten einsehen.

Jetzt Mitglied werden