Anne-Kathrin Woitzik

Selbstständig, IT Quality & Compliance Consultant / Gründerin, Qualitice

Barcelona, Spanien

Fähigkeiten und Kenntnisse

Quality Management
Data Integrity
Computer System Validation
GMP Compliance
GAMP5
Document Lifecycle Management
Agile Software Development
SAP ERP
ARIS modeling
GxP Risk Assessment
Business process management
Intercultural Communication
Geographical Flexibility
International Experience
Health Policy
Market Access
US Reimbursement
LIMS
MES
Regulatory Affairs
Medical Devices
Biotechnology

Werdegang

Berufserfahrung von Anne-Kathrin Woitzik

  • Bis heute 3 Jahre und 2 Monate, seit März 2021

    IT Quality & Compliance Consultant / Gründerin

    Qualitice

  • 2 Jahre, Apr. 2019 - März 2021

    Senior Manager - Quality & Compliance

    Digital Chameleon GmbH
  • 9 Monate, Aug. 2018 - Apr. 2019

    Project Manager (external)

    BASF

    LIMS Implementation

  • 2 Jahre und 9 Monate, Aug. 2016 - Apr. 2019

    Life Science Consultant / Manager

    Kvalito AG

    Plan and implement qualification and validation activities as well as projects of new and existing regulated computerized systems according to internal and external requirements for all departments Advice and support system owners to build and maintain GLP, GCP, and GMP conform systems Conduct assessments and analysis relating to, for example, regulations, policies, standards and scientific literature (FDA,WHO,ICH)

  • 4 Monate, Sep. 2018 - Dez. 2018

    Quality Manager (external)

    Johnson & Johnson

    Actelion Remediation

  • 6 Monate, Sep. 2017 - Feb. 2018

    Data Integrity Specialist, Drug Substance (external)

    Boehringer Ingelheim
  • 1 Jahr und 2 Monate, Aug. 2016 - Sep. 2017

    Manager Computer System Validation (external)

    Fresenius Kabi
  • 4 Monate, März 2016 - Juni 2016

    Analyst, Health Policy & Reimbursement

    Roche Diagnostics Corporation

  • 1 Jahr und 5 Monate, Nov. 2014 - März 2016

    Health Policy and Reimbursement Consultant

    Roche Diagnostics Corporation - Washington DC

    - Monitor and respond to internal and external reimbursement inquiries - Analyze key federal and state policies impacting reimbursement of Roche products - Participate in and report on reimbursement workgroup activities within trade associations and industry coalitions - Develop strategies to maintain and enhance reimbursement for Roche products - Support development of internal guidance on coverage, coding, and payment for all Roche products

  • 3 Jahre und 1 Monat, Sep. 2011 - Sep. 2014

    Roche Leadership Development Program

    Roche Diagnostics Germany

    Various rotations within the Roche Organization on a global level, including the following departments: - Business Development/ Medical Marketing in Mannheim, Germany - Marketing for Advanced Staining Assays in Tucson, AZ - Marketing & Sales for swisslab in Berlin, Germany - Finance & Controlling in Mannheim, Germany - CRM Business Support in Mannheim, Germany - International Call Center in Mannheim, Germany

Ausbildung von Anne-Kathrin Woitzik

  • 1 Jahr und 6 Monate, Feb. 2018 - Juli 2019

    Business Management

    ESEI International Business School Barcelona

  • 6 Monate, Sep. 2012 - Feb. 2013

    International Business

    Universidad Politecníca de Valencia

    World Economy, Macroeconomics

  • 3 Jahre und 1 Monat, Okt. 2011 - Okt. 2014

    International Business

    Corporate State University Baden-Württemberg

    International Finance; International Marketing

Sprachen

  • Deutsch

    Muttersprache

  • Englisch

    Fließend

  • Französisch

    Grundlagen

  • Spanisch

    Gut

Interessen

Wine Tasting
Germanistics
Trends within the Healthcare Industry

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