Dr. Bernd Leschonsky

Bis 2026, Director Quality Systems & Compliance, Thermo Fisher Scientific
Rheinach, Switzerland

Fähigkeiten und Kenntnisse

Quality Management
HQ Quality
cultural transformation
compliance issue resolution/ inspection readiness
global process simplification & standardization
human error reduction
Project & Program Management
international experience/ cultural diversity
experienced in 3 difference business situations (t
Strategy Development
Operational Excellence
International Manufacturing Operations
design control & transfer to production
manufacturing transfer
People Management
Leadership
Risk Management
Regulatory Compliance
People development
Audit
Quality Management Systems
ISO 13485
ISO 14971
FDA Regulation

Werdegang

Berufserfahrung von Bernd Leschonsky

  • 3 years and 7 months, Jul 2022 - Jan 2026

    Director Quality Systems & Compliance

    Thermo Fisher Scientific
  • 6 months, Aug 2021 - Jan 2022

    Sr Manufacturing Director

    Medtronic plc

  • 2 years and 4 months, Apr 2019 - Jul 2021

    VP Quality & Regulatory Affairs

    CTI Vascular

  • 4 years and 7 months, Sep 2014 - Mar 2019

    Director Quality, Swiss Medtronic Operations

    Medtronic plc

  • 2 years and 1 month, Aug 2012 - Aug 2014

    Director Quality & Compliance

    Abbott Vascular, Beringen, Schweiz

    turnaround (address quality and compliance gaps, lead quality Dept at the site), planning and execution of site closure

  • 1 year and 4 months, Apr 2011 - Jul 2012

    Sr. Manager QA Strategy

    Abbott Diagnostics

    Program Quality Manager for large scale, global Strategic Operations programs

  • 1 year and 6 months, Oct 2009 - Mar 2011

    QA Program Manager

    Abbott Diagnostics

    lead 8 global projects which aim for Quality System simplifications and human error reductions (global benchmarking across multiple manufacturing sites, introduction of best-in-class processes and meaningful scorecards, process monitoring, simplified SOPs (Standard Operating Procedures), introduction of picture guides and different learning approach)

  • 1 year, Oct 2008 - Sep 2009

    QA Principle Project Manager

    Abbott Diagnostics

    lead 1 global project which aim for Quality System simplifications and human error reductions (global benchmarking across multiple manufacturing sites, introduction of best-in-class processes and meaningful scorecards, process monitoring, simplified SOPs (Standard Operating Procedures), introduction of picture guides and different learning approach)

  • 2 years and 5 months, May 2006 - Sep 2008

    Quality Control Manager

    Abbott Diagnostics, Sligo, Ireland

    Environmental Monitoring Program; Product Release & Release Testing (review and approval of Investigations, Nonconformances, CAPA, Risk Evaluations, Field Actions)

  • 3 years and 3 months, Feb 2003 - Apr 2006

    Transfer Project Manager

    Abbott Diagnostics, Wiesbaden, Germany

    manufacturing transfer of 8 components and/or final products across international manufacturing sites (Manufacturing Operations)

  • 1 year and 10 months, Apr 2001 - Jan 2003

    Technical Leader

    Abbott Diagnostics, Wiesbaden, Germany

    technical support of 6 different diagnostic assays for the detection of Hepatitis-/ Retroviruses (Manufacturing Operations)

  • 1 year and 2 months, Feb 2000 - Mar 2001

    Molecular Biologist

    Geneart GmbH

    synthetic gene development

Ausbildung von Bernd Leschonsky

  • 9 years and 5 months, Oct 1990 - Feb 2000

    Chemistry, Molecular Biology

    Regensburg

    Molecular Biology, HIV, Immunology, Vaccine Development

  • 2 years and 8 months, Oct 1987 - May 1990

    Chemistry

    Köln

    Biochemie

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

  • French

    A1-A2 (Grundkenntnisse)

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