Mercy Berger

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Oberwil, Basel-Country, Switzerland

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Timeline
About me
Results-driven healthcare professional, QA - GMP|HA inspections| drug dev| ClinOps| CRA |Compliance| integrated patient care & advocacy.
Education
- DIA-Drug Information Association
  -
  Patient Engagement Certificate Program
- GxP Training for life Science Professionals
  2024 -
  Certificate Introduction to cGxP Certificate
  Activities and Societies: Lesson 1: Introduction to GxP guidelines What is GxP GxP vs cGxP Lesson 2: The many faces of GxP Lesson 3: Good Manufacturing Practice (GMP) Lesson 4: Good Laboratory Practice (GLP) Lesson 5: Good Distribution Practice (GDP) Lesson 6: Good Clinical Practice (GCP) Lesson 7: Good Documentation Practice (GDocP)
- European Patients' Academy on Therapeutic Innovation (EUPATI)
  2021 - 2022
  EUPATI Fellow - Patient Expert
  Activities and Societies: EUPATI Fellow
- The University of Georgia
  2024 -
  Quality Basics for Cell and Gene Therapy Products Certificate
  Activities and Societies: https://bip.brightspace.com/b4d73694-f56b-4a94-9221-2e4165c3b806/d2l/awards/assertions/64711/view Define the general principles of cGMP, Quality Systems and Risk Management (GQR)Understand and describe the regulatory framework and current thinking of FDA on cell, and gene therapy product manufacturingInterpret and apply the appropriate GQR Standards for cell, and gene therapy product manufacturing
- University of London
  -
  Bachelor of Science (BSc) Nursing Science
Experience
- Chiltern
  Aug 2003 - Dec 2006
  - Global Clinical Research Associate / Monitor
    Jan 2005 - Dec 2006
  - Research Nurse - phase 1& 2
    Aug 2003 - Dec 2004
- Roche
  Apr 2007 - Jan 2012
  International Clinical Trial Project Manager
- Novartis
  Jan 2013 - Oct 2019
  Global Learning Operations Manager
- Roche
  Oct 2019 - Jun 2022
  Above disease area strategy.
  - Global Patient Partnership - Apprenticeship
    Jan 2022 - Jun 2022
  - Global Leadership Dev & Learning Program Lead
    Oct 2019 - Jan 2022
- Roche
  Nov 2022 - now
  Pharma Technical Quality, IMPQ
  - QA Manager Inspections Lead
    Feb 2025 - now
  - IMP Quality Apprenticeship
    Jul 2024 - Feb 2025
  - Global Patient Partnership Leader
    Jul 2023 - Feb 2025
  - Global Patient Partnership Manager
    Nov 2022 - Aug 2023
Licenses & Certifications
- Eupati Fellow - Patient Expert
  European Patients’ Academy on Therapeutic Innovation
  Oct 2022
- From Ideas to Action
  IDEO
  Jul 2020
- Impactful Presentation
  IDEO
  May 2020
- Strategic Thinking
  LinkedIn
  Jul 2020
  View certificate
- Insights for Innovation
  IDEO
  Jun 2020
- Member
  EUPATI
- Patient Engagement Certificate Program
  DIA
  Feb 2022
  View certificate
- Communicating for Impact
  IDEO
  Jul 2020
- Member
  DIA
- Story Telling for Influence
  IDEO
  May 2020
Volunteer Experience
- Community Volunteer
  Issued by Swiss Red Cross on Jan 2017
  Associated with Mercy Berger