Tanja Rohark

Quality Revolution® with Swiss Excellence | Pharma, MedTech, BioTech, HealthTech

Owner, Geschäftsführerin/ Quality & Compliance Management Consultant, Auditor, Digital Chameleon GmbH

Until 2019, ISO 27001 Information Security Officer and Lead Auditor, TÜV SÜD Gruppe

Basel, Switzerland

Timeline

Professional experience for Tanja Rohark

  • Current , since Mar 2019

    Geschäftsführerin/ Quality & Compliance Management Consultant, Auditor

    Digital Chameleon GmbH

    Quality Revolution with Swiss Excellence As Digital Chameleon, we are helping to create a better world of effective healthcare by driving change for a connected Digital Health Ecosystem We reinvent and transform quality for the digital evolution by navigating our customers through the complex regulatory environment (ISO, FDA, EMA, MDR) in a resilient and secure way.

  • Current , since Jan 2012

    Quality & Compliance Specialist/ Digital Health Software & Computerized Systems

    Rohark Consulting

    Quality Management and Assurance for Software Development of Medical Device Software and Computerized Systems, Regulatory Compliance within Pharmaceuticals and Medical Device industry (EMA, FDA, PIC/S, ISO, MDD), Quality Risk Management (FMEA, ISO 14971), Software Validation and Verification (IEC 623304/82304, GAMP 5/ CSV), Business Analysis/ Requirements and Usability Engineering (BABOK, IREB, IEC 62366), Digital and Mobile Solutions Development, Digital Health, Agile/Scrum, Design Thinking

  • 8 months, May 2014 - Dec 2014

    Consultant Transformation Management

    Novartis Pharma AG

    Transition of Master Data Management and Operational Sourcing from Basel/Switzerland to Hydera-bad/India in PharmaSupply Organization • Business Process Analysis and Optimization, Gap Analysis • Development of value-creation and harmonized processes within all involved functions: Quality, Supply Chain, Sourcing and Finance • Improvement of Standard Organization Procedures (SOP) including process flows • Change Management, Change Communication • Training Development, Training Coordination

  • 7 months, Oct 2013 - Apr 2014

    Project Quality Manager and Analyst (PQM)

    Novartis Pharma AG

    Project Quality Management and Analysis, Oracle Agile, SAP SCM, CSV Computer System Validation

  • 6 months, May 2013 - Oct 2013

    SAP Data Migration Manager

    Novartis Pharma AG

    Supply Chain Management, SAP SCM, SAP Data Migration Management: object identification, mapping, cleansing, conversion, testing, migration, and cutover of approved master and transactional data object

  • 5 months, Dec 2012 - Apr 2013

    Consultant Supply Data Management

    Novartis Pharma AG

  • 3 months, Sep 2012 - Nov 2012

    Consultant Process & Change Management

    Novartis AG, Basel

    BPM Business Process Management, Business Analysis, Change Management, Change Communikation, Projektmanagement, SAP Migration Management, Master Data Management, Supply Chain Management, Trainings, SAP SCM, Training

  • 6 months, Feb 2012 - Jul 2012

    Assistant to Vice President Business Transformation & T-Gallery

    Deutsche Telekom AG, Products & Innovations

    Projektmanagement, PMO, Innovationsmarketing, Transformation, Change Management, PMI Program Management, T-Gallery, Design Thinking, Scrum

  • 2 years and 2 months, Nov 2009 - Dec 2011

    Freie Journalistin & Beraterin für PR/ Presse- und Öffentlichkeitsarbeit

    Fast Fortune - Agentur für Corporate Relations

    Agentur für Corporate Relations: Mensch-zu-Mensch Kommunikation für werteorientierte Unternehmen, kreative und ausgewogene PR-Konzepte & Kampagnen, Public Relations, Online & Media Relations, Communication Design

  • 1 year and 1 month, May 2010 - May 2011

    Redaktionsleitung, Freier TV-Redakteur

    SEEMA Media

    RTL Punkt 12, RTL exklusiv, VOX prominent: TV-Produktion, TV-Reportagen, Magazinbeiträge, Boulevard, Redaktionsleitung, Themenrecherche, Treatments, Texten von Beiträgen, Produktion

  • 1 year and 3 months, Sep 2008 - Nov 2009

    Public Relations & Social Media Manager

    zeitlos; elektronisch

    Kulturmanagement, Künstlermanagement, Musikpromotion, Bookings & Promotion, Kommunikation für die Kultur- und Kreativwirtschaft, Musikwirtschaft und Popkultur, Blog für elektronische Musik und Popkultur

  • 1 year and 6 months, Jun 2008 - Nov 2009

    Public Relations & Social Media Manager

    Sternschaltung - Agentur für Kulturmanagement, PR und Kreativberatung

    Juicy Beats Festival, Audiodigitale Festival für Medienkunst, Artist Marsen Jules: Text und Konzeption Website, Programmheft, Werbemittel, Newsletter, Content und Layout myspace (HTML), Presse-/Medienarbeit, Sponsoring, Bookings, Künstlerbetreuung, Koordination Convention, Newsletter, Online PR auf facebook, myspace, twitter, last.fm, flickr etc.

  • 1 year and 1 month, Sep 2008 - Sep 2009

    Public Relations & Social Media Manager

    kommheim - Kreatives Eventment

    VRSTCK Club & VRSTCK Blog, Dortmund: Text und Konzeption Imagekampagne, Website, Newsletter, PR/Öffentlichkeitsarbeit, Pressarbeit, Content Management, Konzeption und Redaktion Blog, Online PR auf facebook, myspace, twitter, last.fm, flickr etc., Musikprogramm, Bookings & Promotion

  • 2008 - 2008

    Assistenz der Geschäftsführung

    virtual:nights:media Ltd.

    Schwerpunkte: Web 2.0, Social Communities, Onlinemarketing, Online Redaktion, Text und PR/Öffentlichkeitsarbeit, Content Management, Konzeption Werbekampagnen, Eventmanagement: Text und Konzeption Unternehmenspräsentation und Werbemittel, Content Management und Layout Mediawebsite (MODx), Online Redaktion

  • 2006 - 2008

    Assistenz der Geschäftsführung

    Deloitte

    Schwerpunkte: Assistenz des Geschäftsführers, Kundenmanagement, Text und PR/Öffentlichkeitsarbeit, Content Management, Messeplanung- und koordination: Content Management und Layout Unternehmenswebsite (Vignette), Text und Konzeption, Unternehmensbroschüren und Produktflyer, Pressemappe

  • 2005 - 2006

    Assistenz des Abteilungsleiters

    RWE Power AG

    Schwerpunkte: Assistenz des Abteilungsleiters, Koordination des Abteilungs- und Direktionsbüros, Verfassen von Präsentationen und Vorträge

  • 2003 - 2005

    Kontakterin, Event- und Projektmanagement

    Stein All in All Marketing GmbH

    Schwerpunkte: Projektmanagement Sponsorings, Events und Product Placement in TV- und Kinoproduktionen, Text und Konzeption, PR/Öffentlichkeitsarbeit

Educational background for Tanja Rohark

  • Current , Sep 2019 - Jun 2022

    MSc. Information Technologies in Healthcare

    Universität Krems

  • 7 months, Jun 2019 - Dec 2019

    ISO 27001 Information Security Officer and Lead Auditor

    TÜV SÜD Gruppe

  • 1 month, May 2019 - May 2019

    IT & Cybersecurity and Data Privacy for Medical Devices

    Johner Institute

  • 1 month, Oct 2018 - Oct 2018

    Software Engineering

    Johner Institut

    Teacher: Thomas Geis, editor of ISO 9241-100, -110, -112 /IEC 25060 (CIF): Usability engineering, specification and user interfaces design, verification and validation of usability respectively formative and summative usability evaluation, Interaction of development, risk management, Usability file

  • 1 month, Jun 2018 - Jun 2018

    Medical Device Software Development

    Johner Insitut

    •IEC 62304 and FDA •SOUP and legacy software •Risk Management according to ISO 14971 •Quality management

  • Current , Dec 2017 - Dec 2020

    BSc. Klinische Psychologie, Gesundheits- und Rehabilitationspsychologie

    SRH Fernhochschule Riedlingen

  • 1 month, Nov 2013 - Nov 2013

    Quality Assurance Engineering

    Novartis

    CSV/ Project Quality Manager based on PMI: Novartis ICE IQP Crystal Excellence, Six Sigma, Lean Manufacturing

  • 3 months, Apr 2013 - Jun 2013

    Beratung und Coaching

    Hochschule Wismar, University of Technology, Business and Design

    St. Galler Management Modell, Themenzentrierter Interaktionsansatz, Systemische Organisationberatung, Systemische Fragetechniken

  • 7 months, Nov 2012 - May 2013

    Alwart Institut Hamburg

  • 8 months, Feb 2009 - Sep 2009

    Deutsches Institut für Publizistik

Languages

  • German

    First language

  • English

    Fluent

Browse over 18 million XING members