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

• 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, GAMP 5, FDA CSA)
• SaFe Scrum Master, Coach & Organizational Change Manager (ZHAW IAP)

Tanja'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.

Provided Consulting Services are:

• Digital Transformation in Healthcare & Life Science, Digitalization of business processes and modern IT architecture
• Regulatory Compliance and Audits within Pharmaceuticals and Medical Device industry (GxP, EMA, FDA, PIC/S, ISO, MDR, ICH)
• 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)
• Computer System & Software Validation and Verification (IEC 62304/ 82304, GAMP 5 2nd Edition/CSV, FDA CSA)
• Electronic Records & Signatures/ ERES (Annex 11, Part 11)
• Data Integrity, Data Governance & Migration
• Quality & Product Risk Management (FMEA, ISO 14971)
• Information & Cyber Security Management ISO 27001 TÜV SÜD certified Compliance Officer, ISACA/BSI certified Cyber Security Practioner
• Business Analysis and Requirements Engineering (BABOK, IREB)
• Usability & User Experience, Human-Centered Design (UXQB, IEC 62366)
• Business Process Modeling & Transformation, BPMN 2.0
• Digital and Mobile Solutions Development, Cloud Solutions, Data Repository, Digital Health Platforms (IoT), Digital Therapeutics DTx, DIGA, Digital Health Apps, SaMD Software as a Medical Device
• Systemic Organizational Development, Change and Communication Management
• Business Coaching (St. Galler Management Model, Systemic Coaching, solution-resource oriented Counselling, Hypnotherapy, Introvision etc.)
• Agile & Lean Methods, SAFe Scrum Master
• Project Management & Facilitator