Quality & Compliance/ CSV & Medical Device Software Validation/ Business Analyst & Requirement Engineer

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4052 Basel


Quality Assurance for Software Development of CSV Computerized Systems and Medical Device Software in the regulated Life Science and Digital Health Sector, Business Analyst & Requirements Engineer with Coaching and Change Management background

Ich biete

Management, Unternehmen, Strategie
  • Change Management
  • Auditor
  • Business Analyse
  • Transformation Management
  • Risikomanagement
IT, Entwicklung
  • Qualitätsmanagement / QS / QA (IT)
  • Projektmanagement (IT)
  • Schulung / Training (IT)
  • Requirement Analyse
  • Prozessoptimierung

Projekt‐ & Berufserfahrung

Quality & Compliance Strategy Consultant, Medical Device Software
Fresenius Kabi Digital Labs GmbH, Berlin
2/2018 – 12/2018 (11 Monate)

2/2018 – 12/2018


Service Delivery and direct report to Managing Director Digital Labs Healthcare
Fresenisu Kabi Digital Labs GmbH, Berlin
• Conception and Realization of Computer System Validation Framework for new Fresenisu Kabi entity to ensure Quality Assurance and Compliance of gxp-relevant Medical Device Software, Digital and Mobile Solutions, combining Agile/ Scrum Methology and Medical Device Validation
• CSV/ Software Validation of Digital and Mobile Solutions for the Digital Labs
• CSV/ Software Validation of JIRA Confluence for usage as validated Project and Documentation Software
• Quality Management support to implement Quality Management System ISO 134585 and ISO 9001 into Digital Labs

Eingesetzte Qualifikationen

Gesundheitswesen, Good documentation practice (GDP, GDocP), Confluence (Atlassian), DIN ISO/IEC 27001, Qualitätsmanagement / QS / QA (IT), Jira, Auditor, DIN EN ISO 13485

IT Quality and Compliance Strategy Consultant, Senior Business Analyst & Process
Kundenname anonymisiert, weltweit
12/2017 – 12/2018 (1 Jahr, 1 Monat)
Life Sciences

12/2017 – 12/2018


IT Quality and Compliance Strategy Consultant, Senior Business Analyst & Process Expert
Service Delivery and direct report to Head of Global Quality and Global IT Management for Global Pharma & Medical Device customer

• Conception and Realization of a Global Competence Center for Computer System Validation to ensure worldwide Quality Assurance and Compliance of gxp-relevant IT systems and projects, including im-plementation of CSV Knowledge Management and Quality Assurance Unit worlwide
• Conception and Process Design of One Global IT Architecture Landscape for a validated Global Applica-tion Lifecycle Management, integrating all Global IT Systems through harmonized Business Process & Business Requirement Management, System Specification and Test Case Design (using ARIS BPM Tool), including Change Control and Change Impact Analysis
• CSV/ Validation of ARIS BPM Tool to manage all business process/ system changes and validation doc-umentation (URS, FS, RA, Test Scripts) within ARIS (validated Approval workflow without print outs)
• Conception and Realization of CSV Framework and QMS for the new Digital Lab of Frensenius (Digital Healthcare and Mobile Devices), implementing Confluence as validated Project and Documentation Software
• CSV/ Validation of new implementation of Service Now Discovery
• CSV/ Validation of global Archive System in compliance with Data Integrity and EU-DSGVO, creation of business requirements and SOPs/ WIs in regrads to Data Integrity and ERES regulations

Eingesetzte Qualifikationen

Projektmanagement (IT), Qualitätsmanagement / QS / QA (IT), Transformation Management, Wissensmanagement, Auditor, Qualitätsmanagement (allg.), Business Analyse

IT Quality and Compliance Risk Consultant
Kundenname anonymisiert, Basel
6/2016 – 12/2017 (1 Jahr, 7 Monate)
Life Sciences

6/2016 – 12/2017


• Develop and integrate appropriate risk based models for CSV activities of GxP systems
• Support the development and drive the implementation of Risk Management Strategy in line with quality and regulatory requirements to ensure effective and compliant quality oversight over GxP computerized system
• Monitor risks and deviations related to GxP computerized systems and computer system validation to ensure gaps are identified, adequately addressed and documented
• Support throughout several project deliveries with regards to aspects of project related risk, compli-ance and quality
• Track quality and compliance risks for ongoing projects, perform root cause analysis on trends and address deviations via preventive, detective and corrective measures
• Ensure adequate analysis have been performed for relevant testing conditions based on functional risk assessment, test overview list, test plan, test results, test deviations and change requests.

Eingesetzte Qualifikationen

FMEA (Failure Mode and Effects Analysis), Qualitätsmanagement / QS / QA (IT), Auditor

IT Quality & Compliance/ CSV Strategy Consultant
Fresenius Kabi, Bad Homburg
1/2016 – 8/2016 (8 Monate)
Life Sciences

1/2016 – 8/2016


Strategieberatung in globalen IT-Applikation RollOuts (SAP, EMC LS, TrackWise)
Verfassung von Validation (Master) Plänen, Durchführung von GxP Risk Assessments

• Giving Strategy and Advice to establish a Corporate Framework for Project Governance of Computer System Validation (risk-based approach GAMP5)
• Ensure the Corporate Framework and corresponding Global Operating Procedures are fully integrat-ed into Fresenius Kabi Global IT Strategy
• Ensure that computer system validation strategy is effectively implemented for all GxP systems and that they remain compliant throughout their life-cycle
• Support the development of compliance standards (e.g. Global Operating Procedures, templates, and training materials) as well as IT project related documents in line with Fresenius quality and regulatory requirements in the respective IT function.
• Liaise effectively with Quality and IT personnel across Fresenius Kabi as well as other Divisional quality and business functions to ensure that standards and effective processes for governing GxP computer-ized systems are in place, maintained and opportunities for continuous improvement identified and implemented
• Support the development and delivery of training relevant for Quality, IT and business functions in the area of computerized systems compliance

Eingesetzte Qualifikationen

Testmanagement / Testkoordination (IT), Qualitätsmanagement / QS / QA (IT), SAP Rollout, IT-Beratung (allg.), Risikomanagement, Unternehmensberatung, Auditor

IT Quality & Compliance/ CSV Validation Consultant
Novartis Pharma AG, NBS, Basel
10/2015 – 12/2015 (3 Monate)
Life Sciences

10/2015 – 12/2015


Quality and Compliance Consultant/ IT Assessor with focus on IT Transition, Information Governance and Risk Management
ITIL Transition Project, Digital and Commercial Solutions
Novartis AG, Basel, Switzerland
• Ensuring that the transition projects and applications are managed in compliance with different No-vartis Quality Standards, e.g. IGM, QM and the Novartis project methodology ICE
• Validating all project and system life cycle documents in compliance with Novartis Quality Standards to force the acceptance of transition
• Verify that all project-related tests are conducted according to the project quality plan and in compli-ance with Novartis Quality Standards
• Perform quality reviews for audit readiness, identify and document all project observations, gaps and risk with associated mitigation strategies
• Support the problem solving of project deviations/errors and provide quality guidance on GxP regula-tory requirements (including, but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.)
• Schedule sessions with Project and Operations Team to drive mitigation actions on gaps and risks
• Ensure Acceptance Meetings, Knowledge Transfer and Asset identification for project transition

Eingesetzte Qualifikationen

IT-Governance, Qualitätsmanagement / QS / QA (IT), Schulung / Training (IT), Risikomanagement, Transition Management, Transformation Management, Auditor

IT Project Manager/ Business Technology Analyst
Novartis Pharma AG, Basel
5/2015 – 10/2015 (6 Monate)
Life Sciences

5/2015 – 10/2015


ArtBase is Documentum D2 based system which supports review, approval and retrieval of artworks for printed packaging materials for Novartis Pharma. The system is used by 800 users worldwide.

Senior IT Business Analyst with focus on Business Analysis, Requirements Engineering and Test Management
Artwork Document Management Software Project, Artwork Operations
Novartis AG, Basel, Switzerland
• Design of Test Cases (PQ Testing) ensuring coverage of user requirements
• Authoring of Test Specifications
• Coordinate Test Execution with Subject Matter Experts
• Prepare and Conduct pre-go-live and post-go-live/ hypercare sessions taylored for the different end user groups of 800 user worldwide

Eingesetzte Qualifikationen

Projektmanagement (IT), Testmanagement / Testkoordination (IT), Testdesign (IT), Migration, Schulung / Training (IT), Requirement Analyse, Dokumentation (IT), Change Management, Business Analyse

Senior IT Business Analyst Logistics & Manufacturing
Novartis Pharma AG, Stein
12/2014 – 9/2015 (10 Monate)
Life Sciences

12/2014 – 9/2015


Senior IT Business Analyst Manufacturing and Logistics, IT Service Management
Interim Management at Local IT, Manufacturing and Logistics
Novartis AG, Basel, Switzerland
• Managing Service Delivery Management: incident, service request and change management processes for IT applications of the integrated IT warehousing, material flow and distribution system environment in PharmOps Switzerland (MES, SAP WM (ERP), GISC Labeling and Material Movement Controller
• Support and demand management for the ‘SU Process and Logistics Services’ concerning application operations and projects (e.g. warehouse refurbishment, weighing & dispensing)
• ‘Translating’ business and engineering requirements for IT suppliers to realize IT solutions via changes and projects

Eingesetzte Qualifikationen

Incident Management, Projektmanagement (IT), IT Service Management (ITSM), SAP MM-PUR, SAP EWM, SAP PP, Schulung / Training (IT), Requirement Analyse, Manufacturing execution system (MES), Change Management, Business Analyse, Pharmazie

Project Manager, Business Process Analyst MRP II Business Excellence
Novartis Pharma AG, Basel
10/2014 – 12/2014 (3 Monate)
Life Sciences

10/2014 – 12/2014


Business Process Analyst, Projekt zur Implementierung von SAP Master Data Governance in Pharma Supply Chain basierend auf MRP II Class A Business Excellence.

Project Manager with focus on Change and Communication Management, Business Process Analysis
Business Transformation and Transition Project, Supply Chain Excellence, MRP II Class A
Novartis AG, Basel, Switzerland
• Leading the Transition of Master Data Management and Purchasing from Basel/Switzerland to Hyder-abad/India in Pharma External Supply Organization
• Accompany of NOSSCEE (Novartis Operational Standards for Supply Chain Excellence), Project to es-tablish Global Supply Chain Excellence and KPI Reporting to target a MRP2 Class-A Certification, au-dited by Oliver Wright Company
• Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports, risk plan including targets, milestones, resources, cost, expenses
• Business Process Analysis, Gap Analysis and Optimization
• Development of value-creation and harmonized processes within all involved functions: Quality, Sup-ply Chain, Sourcing and Finance
• Stakeholder Management
• Change Management, Change Communication
• Training Development, Training Coordination
• Improve Business Process including KPI Reporting of Master Data Management and Operational Sourcing to handover to new Master Data Team in Hyderabad/India (Business Process Offshoring/ Outsourcing)
• Delivered Change and Communication Strategy including Stakeholder Management
• Delivered Workshops, Trainings and Onboarding Strategy for new Master Data Team in India and all effected users and stakeholders

Eingesetzte Qualifikationen

Projektmanagement (IT), SAP MDG, SAP MM, Schulung / Training (IT), Prozessoptimierung, Prozess- / Workflow, Manufacturing resources planning (MRPII), Change Management, Transformation Management, Business Analyse, Schulung / Coaching (allg.), Supply-Chain-Management (SCM)

Project Manager, Transformation Management, Business Offshoring
Novartis Pharma AG, Basel
5/2014 – 10/2014 (6 Monate)
Life Sciences

5/2014 – 10/2014


Project Manager Change and Communication Management, Business Process Analysis
Business Transformation Project with SAP SCM integration, Supply Chain Management
Novartis AG, Basel, Switzerland
• Establishment of Master Data Organization in External Supply Chain Management
• Establishment of Supply Data Manager job role
• Integration of MDM Team to ESO Organization
• Business and IT Process Analysis and Optimization
• Improvement of Standard Organization Procedures including process flows
• Training Development, Training Coordination
• Change Management, Change Communication
• Drive the organizational Change in Master Data Organization and make sure the functional solution fits to the global and local structures
• Delivered Change and Communication Strategy including Stakeholder Management
• Delivered Workshops and Trainings for users and stakeholders

Eingesetzte Qualifikationen

SAP MDM, Telekommunikation / Netzwerke (allg.), Schulung / Training (IT), Prozessoptimierung, Prozess- / Workflow, IT-Beratung (allg.), Change Management, Transformation Management, Projektmanagement, Offshoring, Kommunikation (allg.), Schulung / Coaching (allg.)

IT Quality and Compliance Manager CSV GxP
Novartis Pharma AG, Basel
10/2013 – 5/2014 (8 Monate)
Life Sciences

10/2013 – 5/2014


IT Quality and Compliance Manager with focus on Computerized System Validation
Change Control Project with Oracle Agile integration, Global Technical Operations, Supply Chain
Novartis AG, Basel, Switzerland
• Implementation of an integrated GXP-system based on Oracle Agile PLM to change control and sup-port product information management of regulatory relevant information for Pharma
• Preparation of key Computerized System Validation documents, such as Validation Plan and Validation Report
• Coordination of the preparation of documents by adequate stakeholders
• Management of the review, approval and implementation process of project deliverables
• Definition of the Tollgate Report, tracking of Tollgate deliverables
• Delivered Validation Strategy
• Delivered compliant system, no incidents
• Improved Project Documentation Management by implementing new concept for document archiving and approval process including Training for all writers and users

Eingesetzte Qualifikationen

Oracle (allg.), Qualitätsmanagement / QS / QA (IT), Schulung / Training (IT), Produktlebenszyklusmanagement (PLM), Oracle Agile PLM, Compliance management, Archivierung, Dokumentenmanagement

IT Business Analyst, SAP Data Migration Manager
Novartis Pharma AG, External Supply Operations, Basel
5/2013 – 10/2013 (6 Monate)
Life Sciences

5/2013 – 10/2013


Co-ordination of activities between Data owners (Functional and Business), as well as development team and quality manager, to ensure documentation is delivered, approach is followed and quality of the data migration is achieved. provide the data migration strategy, and coordinate testing activities and ensure testing is delivered according to the standards of the project.

IT Business Analyst, SAP Data Migration Manager
SAP Data Migration Project, Supply Chain Management
Novartis AG, Basel, Switzerland
• Integration of API Drug Substance and SRM Strategic Raw Material business in one single SAP plant for Multimarket business and Switzerland in Pharma Supply Chain
• Development of the data migration methodology & implementation plan
• Development of best practice, processes and standards for effectively carrying out data migration ac-tivities
• Analysis, cleansing, harmonization and migration of data
• Coordination of testing activities
• Change Management, Change Communication
• Training Development, Training Coordination
• Delivered Migration and Cutover Strategy
• Assessed and delivered clean and proper Data for data migration activities

Eingesetzte Qualifikationen

Hardware Entwicklung, Testing (IT), SAP MM-PUR, SAP Beratung (allg.), SAP SCM, Migration, Schulung / Training (IT), Requirement Analyse, Prozessoptimierung, Prozess- / Workflow, Produktdatenmanagement (PDM), Business Analyse, Supply-Chain-Management (SCM)

Project Manager, Business Process Optimization
Novartis Pharma AG, Basel
10/2012 – 5/2013 (8 Monate)
Life Sciences

10/2012 – 5/2013


Project Manager Supply Master Data Management, Business Process Modelling and Engineering
SAP – New Plant Implementation Project, Supply Chain Management
Novartis AG, Basel, Switzerland
• Implementation of a new SAP plant to concentrate all business operations for multimarket and Euro-pean external supply activities in Pharma External Supply Organization
• Leading the Workstream for Master Data Management
• Direct reports to Head of Supply Chain and Steering Committee: project charter, project plan, project report, status reports, risk plan including targets, milestones, resources, cost, expenses
• Business Process Analysis and Optimization
• Development of value-creation and harmonized processes within all involved functions: Quality, Sup-ply Chain, Sourcing and Finance
• Change Management, Change Communication
• Training Management, Training Coordination
• Developed of Master Data Maintenance Strategy for Material, Vendor and Quality Master Data
• Delivered Concept for Master Data Governance

Eingesetzte Qualifikationen

Projektmanagement (IT), SAP MM-PUR, SAP SCM, Schulung / Training (IT), Requirement Analyse, Prozessoptimierung, Prozess- / Workflow, Produktdatenmanagement (PDM), Change Management, Transformation Management, Projektmanagement, Business Analyse, Supply-Chain-Management (SCM)

PMO/Projektassistenz Business Transformation & Program Management
Deutsche Telekom AG, Products & Innovation, Produc, Bonn
2/2012 – 8/2012 (7 Monate)

2/2012 – 8/2012


Aktueller Projekteinsatz:

Seit Februar 2012 bin ich als freie Projektassistentin des Vice President Design Transformation (Innovationsmarketing) & T-Gallery (Event & Programm Management) bei der Deutschen Telekom AG im Fachbereich Products & Innovations, Product Design im Einsatz.

Meine Schwerpunkte dort:
Design Transformation (Innovationsmarketing) & Program Management (PMI) zur Steuerung der erfolgreichen Transformation aller strategischen sowie Business- und Markenrelevanten Experience und Design Themen innerhalb und außerhalb des Konzerns sowie der Produkt- und Innovationsentwicklung von Trend- und Zukunftsbilder in dem Zukunftsforum T-Gallery.

Meine Aufgaben:
Assistenz des Vice President, Koordination und Administration PMO Design Transformation & T-Gallery in Scrum-Teams, sowie dem Change-Projekt:Talent Management, Konzeption und Text im Innovationsmarketing, Reporting Design Management

Deutsche Telekom AG, Bonn, Germany
• PMO/Project Management Officer to Program Manager Product Design & Innovations, Telekom Inno-vation Labs, Virtualized Infrastructure & Global Cloud IT, User Experience Design
• Project Management for Design Transformation and Global Talent Management, Change Management, Change Communication, Concepts & Text, Design Thinking, Agile/Scrum
• Improve Talent Management Strategy to hire worldwide the most talented Designers for Deutsche Telekom Product Design

Eingesetzte Qualifikationen

SCRUM, Change Management, Transformation Management, Projektmanagement, Talentmanagement, Produktdesign

Redaktionsleitung, Freie TV-Redakteurin
RTL Television, Köln
5/2010 – 5/2011 (1 Jahr, 1 Monat)

5/2010 – 5/2011


TV-Redaktion und -Produktion von Reportagen und Magazinbeiträgen für RTL Punkt 12, RTL exklusiv, VOX prominent

Chief Editor/ TV-Journalism & TV-Production
Various TV Projects
RTL Television, Cologne, Germany
• TV Editorial, TV Production, Television reports, features, magazines, RTL Punkt 12, RTL exklusiv, VOX prominent
• Developed TV-Production concept and editorial for TV-Features with ViPs like Topmodel Franziska Knuppe, Fashion Designer Talbot & Runhof and Guido Maria Kretschmar

Eingesetzte Qualifikationen

Redaktion (allg.), Journalismus, Produktions- / Aufnahmeleitung, Film / Fernsehen (allg.)

Projekt Manager - Online & Digital Marketing
Virtual Nights Media, Essen
1/2008 – 6/2008 (6 Monate)

1/2008 – 6/2008


Schwerpunkte: Projektmanagement, Online Marketing, Online Redaktion, Content Management, Eventmanagement, CRM

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

Project Manager – Online and Digital Marketing
Various Projects
Virtual Nights Media Ltd, Essen, Germany
• Online Editorials, Internet/Intranet Content Management, CRM, Social Media, Festivals and Incentives, Conception, Campaigning, Branding
• Developed Sponsoring and Communication Concept for Love Parade Dortmund and other interna-tional Events and Festivals
• Developed new Micro-Website for Customer Services in TYPO 3

Eingesetzte Qualifikationen

Projektmanagement (IT), Typo3, Telekommunikation / Netzwerke (allg.), Internet / Intranet, Marketing (allg.), Sponsoring, Event Marketing / Event management, Online Marketing, CRM (Costumer Relationship Management), Kommunikation (allg.), Public Relations, Layout / Satz, Content Management, Medien (allg.)

Freie Journalistin, Kommunikationsberaterin für PR/ Presse- und Oeffentlichkeits
Symphony of Elements & Fast Fortune, Köln
11/2007 – 2/2012 (4 Jahre, 4 Monate)

11/2007 – 2/2012


SOEPR - Initiative für Presse- und ßffentlichkeitsarbeit: Public Relations, Beratung, Medienarbeit, Textservice, Online Kommunikation, Grafik, Audio & TV

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

Corporate Communication Manager, Public Relations Officer
Various Projects & Clients (Deutsche Telekom, Deutsche Post, RTL Television, Versatel, Runners Point)
Agency for Corporate Communication and Strategy, Corporate Branding, Public and Social Media Relations, Digital Marketing and Design, Cologne, Germany
• Consulting for Strategy, Conception, Campaigning, Branding, Public Relations, Online & Social Media Relations, Digital Marketing, Corporate and Web Design
• Social Media Management, Journalism, Editorials
• Event Management, Incentives
• Art & Culture Management, Bookings and Promotion
• Developed Communication and Marketing strategies, that foster innovation in the digital space by adding cross-domain, cross-functional expertise on technology and business trends
• Reference Project: Developing and implement “VERSA” as digital avatar for VERSATEL to enforce Cus-tomer Relationship and Online Reputation Management on twitter, Facebook and diverse online fo-rums (First Online Avatar in Germany)

Eingesetzte Qualifikationen

Change Management, Projektmanagement, Event Marketing / Event management, Online Marketing, Social Media Marketing, Kommunikation (allg.), Public Relations, Unternehmenskommunikation, Kommunikationsberatung, Grafikdesign, Webdesign, Design (allg.), Journalismus, Medien (allg.), Film / Fernsehen (allg.), Kunst (allg.)

PA/ Assistenz der Geschäftsführung (Festanstellung)
Deloitte, Düsseldorf
2/2006 – 1/2008 (2 Jahre)
Unternehmensberatung und Wirtschaftsprüfung

2/2006 – 1/2008


Schwerpunkte: Assistenz des Geschäftsführers, Teamassistenz Energie, Managementsysteme, Emissionshandel und Nachhaltigkeit (CSR), Presse- und ßffentlichkeitsarbeit, Messeplanung und -koordination

Eingesetzte Qualifikationen

ISO 14001 (Umweltmanagement), Umweltschutz (allg.), Qualitätsmanagement (allg.), Vorbereitung auf QM-Zertifizierung (ISO), DIN EN ISO 14001, Auditor, DIN EN ISO 9001, Event Marketing / Event management, Public Relations, Energiehandel

PA/ Assistenz des Abteilungsleiters (Festanstellung)
RWE AG, Kraftwerksbau, Umweltschutz und Emissionsh, Essen
3/2005 – 2/2006 (1 Jahr)
Öl- und Gasindustrie

3/2005 – 2/2006


Schwerpunkte: Persönliche Assistenz des Abteilungsleiters, Teamassistenz Umweltschutz und Emissionshandel, Koordination des Abteilungs- und Direktionsbüros, Verfassen von Präsentationen und Vorträge, Projektmanagement Support

Eingesetzte Qualifikationen

Kraftwerksbau, ISO 14001 (Umweltmanagement), Wasserversorgung / Abwasserentsorgung, Umweltschutz (allg.), Projektmanagement, Qualitätsmanagement (allg.), Vorbereitung auf QM-Zertifizierung (ISO), Energiehandel

PA/ Assistentin Leiter Corporate Communications (Festanstellung)
Evonik AG, Düsseldorf
3/2004 – 3/2005 (1 Jahr, 1 Monat)

3/2004 – 3/2005


Interim Assistentin, Persönliche Assistenz des Leiters Unternehmenskommunikation und des Leiters Corporate Branding & Public Relations, Projektmanagement, Eventmanagement, Content Management

Eingesetzte Qualifikationen

Projektmanagement, Markenmanagement, Event Marketing / Event management, Public Relations, Unternehmenskommunikation, Content Management

Projektleiter Marketing, Konzepter (Festanstellung)
Stein/ Movie Art Marketing, Dortmund
9/2002 – 12/2003 (1 Jahr, 4 Monate)

9/2002 – 12/2003


Schwerpunkte: Projektmanagement, Eventmanagement, Incentives für Deutsche Post, Kamps etc., Sponsoring, Product Placement in TV- und Kinoproduktionen, Text und Konzeption

Eingesetzte Qualifikationen

Projektmanagement, Projektmanagement - Konzeption / Vorgehensmodell, Marketing (allg.), Event Marketing / Event management, Sponsoring, Texter, Film / Fernsehen (allg.)


Resilience Engineering/ Human Factors & Human-Machine Interaction (ISO 31000)
Dezember 2018

Multi Project & Portfolio Management
Dezember 2018

Risk Management for Medical Devices (ISO 14971)
November 2018

Certified Professional for Requirements Engineering (CPRE)
Oktober 2018

Human Factors/ Usability Engineering (IEC 62366, IEC 60601, ISO 14971, FDA)
September 2018

Medical Device Software Development, Validation and Verification
Juni 2018

IT Project Quality Manager (based on PMI and CSV, GxP), Novartis
November 2013

SAP Supply Data Manager (Novartis Pharma)
Juni 2013

Novartis Project Management (based on PMI, Lean/Six Sigma)
September 2012


Klinische Psychologie, Gesundheits- und Rehabilitationspsychologie
(Bachelor of Science)
Jahr: 2020
Ort: SRH Heidelberg

Business Analysis and Engineering
(DIPLOM BUSINESS ANALYST NDS HF, Postgraduate Diploma of Federal Higher Education)
Jahr: 2018
Ort: SIB Schweizerisches Institut für Betriebsökonomie,

Systemischer Business Coach (Uni of A. Sciences, DVCT)
Jahr: 2014
Ort: University of Applied Science Wismar

Systemischer Change Berater & Organisationsentwickler
Jahr: 2012
Ort: alwart institut Hamburg

Deutsches Institut für Publizistik
(Journalist für Pressestellen und Öffentlichkeitsarbeit )
Jahr: 2009
Ort: Hagen

Jahr: 2002
Ort: Hülpert & Co. VW/AUDI, Dortmund

Abitur Wirtschaftswissenschaften
Jahr: 1999
Ort: Unna


• BPMN 2.0 BUSINESS PROCESS MODEL AND NOTATION, Certificate, SGO Zürich (10/2017 – 04/2018)
• MULTIPROJEKTMANAGEMENT, Certificate, SGO Zürich (10/2017 – 04/2018)
• CLINICAL AND HEALTH PSYCHOLOGY, Bachelor of Science, SRH Riedlingen, (2018 – 2021)
• eREGULATORY AND INTELLIGENCE/ ISO IDMP, Drug Information Association DIA, Philadelphia/US (06/2015)
• SYSTEMIC BUSINESS COACHING/ St. Galler Management Model, University of Applied Sciences: Technology, Business and Design, Wismar (02/2014)
• CERT. PROJECT QUALITY MANAGER, IT-Project Management & Computer System Validation in pharmaceutical industries, Novartis (11/2013)
• SAP DATA MIGRATION MANAGER (Novartis Project Role to implement API Business) (2013)
• SUPPLY DATA MANAGER SAP SCM/ Supply Chain Data Management in pharmaceutical industries, Novartis (02/2013)
• OPERATIONAL SOURCING MANAGER SAP SCM/ Contract & Price Management in pharmaceutical industries, Novartis (06/2014)
• JOURNALIST FOR PUBLIC RELATIONS & PRESS OFFICE MANAGEMENT, German Institute for Publicity & Journalism, Hagen (09/2008)

Business Software, Hardware, Firmware
• ITSM IT Service Management – BMC Remedy ITSM Suite, SAP NetWeaver, SAP Solution Manager
• Service Now Discovery for IT Infrastructure
• JIRA Service Desk for IT Demand Management
• JIRA for Software Development
• JIRA CONFLUENCE Content Collaboration-Software
• ERP – SAP SCM, MM-PUR, WM, PP, PM Plant Maintenance, MMP Procurement (Material Management) incl. all objects: BOM, PR, SL, Contract and Purchase Order, Order Fulfillment (Sales Order Management), Vendor Master Data (including SIM Tool authorization), Quality Master Data, R/3 HR, ESS
• SAP Hana Cloud (Application for Digital Home & Healthcare)
• MES Manufacturing Execution Systems (ATLAS, PAS-X, PMX), MMC Material Movement Controller
• Test Management - HP Quality Center/ PROTON Test Software, SAP Solution Manager (Implementation, Test Workbench)
• BPM Business Process Modelling – ARIS
• CMS Content Management – Vignette, Microsoft Office SharePoint Server (ECM), MODx, TYPO3, Wordpress, HTML
• Document Management - Documentum D2, Veeva, Microsoft SharePoint
• CRM Customer Relationship Management – Mamis (Deloitte), vtiger, Daylite, salesforce
• Project Management - Microsoft Project, Biquanda (ehem. OpenTime), Open Workbench, Scifor-ma, Project Scheduler, GRANEDA Dynamic, GANTT project, MindManager

Über mich

IT Quality & Compliance and Business Analysis & Requirements Engineering Specialist for Software Deve-lopment of Medical Device Software and Computerized Systems with Coaching, Change and Communication Management background and strong experience in global IT and Business Transformation Programs

• More than 18 years’ experience in global corporate positions and multi-cultural and multi-disciplinary projects and programs
• 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 Quality Management and Assurance for Software Development of Medical Device Software and Computerized Systems
o Regulatory Compliance within Pharmaceuticals and Medical Device industry (EMA, FDA, PIC/S, ISO, MDD)
o Quality Risk Management (FMEA, ISO 14971)
o Software Validation and Verification (IEC 623304/82304, GAMP 5/ CSV), Usability Testing
o Business Analysis/ Requirements and Usability Engineering (BABOK, IREB, IEC 62366)
o Business Process Modeling & Transformation, BPMN 2.0
o Digital and Mobile Solutions Development, Digital Health, Agile/Scrum, Design Thinking
o Change and Communication Management
o Systemic Organizational Development
o Systemic Business Coaching (St. Galler Management Modell)

Persönliche Daten

  • Deutsch (Muttersprache)
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