Klaus Goodwin

is working from home. 🏡

Freiberuflich, R&D Quality Consultant, FDAQRC
Abschluss: certified Lean Six Sigma Black Belt, Oriel
Dubois, United States of America

Fähigkeiten und Kenntnisse

I'm passionate about process design
continuous (process) improvement
compliance and strategic transformation
and don't hesitate to jump into any new change cha
Pharmaceuticals
Consulting
Leadership
Coaching
Quality Management
Prozesse
Quality Assurance
Total Quality Management (TQM)
Team leadership
Project Management
Lean Six Sigma

Werdegang

Berufserfahrung von Klaus Goodwin

  • Current 2 years and 5 months, since Jan 2024

    R&D Quality Consultant

    The FDA Group

  • Current 2 years and 5 months, since Jan 2024

    R&D Quality Consultant

    FDAQRC

  • Current 2 years and 7 months, since Nov 2023

    President

    Goodwin R&D Quality Consulting, LLC

  • 2 years and 5 months, Sep 2021 - Jan 2024

    Exec. Director, Global R&D Quality & Compliance

    Organon

  • 5 years and 10 months, Feb 2016 - Nov 2021

    President

    Beach Spa Bed & Breakfast

  • 1 year and 5 months, May 2020 - Sep 2021

    Sr. Director, Research & Clinical Development Quality Operations

    Alexion Pharmaceuticals

  • 6 years and 2 months, Aug 2015 - Sep 2021

    Principal Consultant

    Goodwin GCP Consulting

    Global Quality and Process Leadership, as well as Compliance Oversight Services to (Bio-) Pharmaceutical Companies

  • 8 months, Aug 2018 - Mar 2019

    Sr. Director, Head GxP Quality Assurance

    Alkahest Inc.

  • 10 months, Nov 2017 - Aug 2018

    Sr. Director, Head of Quality

    Firma Clinical Research

  • 1 year and 10 months, Jan 2016 - Oct 2017

    Head, QA Clinical

    Indivior

  • 8 months, Jan 2015 - Aug 2015

    Director Clinical Compliance, Process & Procedures

    Regeneron Pharmaceuticals

  • 1 year and 2 months, Sep 2013 - Oct 2014

    Director R&D Compliance, Global Head Quality Systems

    Biogen Idec

  • 1 year and 3 months, Jul 2012 - Sep 2013

    Director Process Quality Management

    PAREXEL International

  • 9 months, Oct 2011 - Jun 2012

    Director Business Process Excellence

    PAREXEL International

  • 2 years, Oct 2009 - Sep 2011

    Director Process Quality Management, Project Mgmt/Business Operations - EP WW

    PAREXEL International

  • 1 year and 2 months, Aug 2008 - Sep 2009

    Director Quality Management, Clinical Data Services Early Phase Worldwide

    PAREXEL International

  • 1 year and 1 month, Aug 2007 - Aug 2008

    Associate Director Quality Management, Early Phase Clinical Unit Baltimore

    PAREXEL International

  • 4 years and 1 month, Jul 2003 - Jul 2007

    Quality Specialist and Quality Manager, Early Phase Clinical Unit Berlin

    PAREXEL International

  • 4 years and 8 months, Nov 1998 - Jun 2003

    (Senior) Volunteers Recruiter and Regulatory Affairs Associate

    PAREXEL International

Ausbildung von Klaus Goodwin

  • 3 years and 1 month, Jul 2008 - Jul 2011

    Lean Six Sigma

    Oriel

  • 2005 - 2007

    Quality Management

    Deutsche Gesellschaft fuer Qualitaet (Germany)

  • 2 years and 1 month, Oct 1996 - Oct 1998

    Psychology

    Universitaet Potsdam (Germany)

  • 2 years and 2 months, Sep 1991 - Oct 1993

    Translator/Interpreter - Business Adminstration - French/English

    Wuerzburger Fremdsprachenakademie/Dolmetscherschule (Germany)

  • 5 years and 10 months, Oct 1985 - Jul 1991

    Theology

    Julius-Maximilian-Universtaet, Wuerzburg (Germany)

Sprachen

  • English

    C1 (Fließend)

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • French

    B1-B2 (Gute Kenntnisse)

  • Italian

    A1-A2 (Grundkenntnisse)

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