Nicolas SAVY

Bis 2025, Validation Lead, Philip Morris International
Abschluss: Master, BEM Management School
Neuchâtel, Switzerland

Fähigkeiten und Kenntnisse

cGMP
Computer System Validation
Validation
21CFR part 11
GxP trainer
cleaning validation
ASTM 2500e
Supplier Evaluation
CAPA
Quality Improvement
Quality by Design (QbD)
Inspection Readiness & Compliance
Leadership & Human Impact
FDA 21 CFR 11/210/211/820
EudraLex Annex 1/11/15/22
ICH Q7/Q10
ISO 9001/13485/17025/42001 OECD PIC/S.
Digital Quality & AI Enablement
CSV/CSA/CQV
Cleaning Validation Data Integrity
ALCOA+ ASTM E2500 GAMP 5
Lifecycle Management
audit readiness
risk management continuous improvement
SaaS validation
AI-augmented QA insights
Digital Quality Transformation
ISO
KPI
Mondialisation
Pharmacie

Werdegang

Berufserfahrung von Nicolas SAVY

  • 7 years, Oct 2018 - Sep 2025

    Validation Lead

    Philip Morris International

    Owned global CSV/CSA and Data Integrity governance for PMI’s Life Sciences R&D network, covering ISO/IEC 17025 QC laboratories, one GLP laboratory, laboratory instruments and associated computerised systems. Acted as technical authority and escalation point for validation methodology, Data Integrity, periodic reviews, changes, deviations and CAPA. For details, refer to my LinkedIn account: https://www.linkedin.com/in/nicolassavydigitalqalead/

  • 1 year and 5 months, May 2017 - Sep 2018

    Senior Validation Consultant

    GxP Consulting Switzerland

    Delivered remediation plans, QMS improvements, audit-readiness support, and validation governance for major pharmaceutical and biotechnology clients. J&J: Defined and executed a structured CSV remediation plan, coached the assigned consultant and restored an inspection-ready validation state. Bracco: Acted as interim Validation Manager for aseptic processes. Led CSV remediation activities. For details, https://www.linkedin.com/in/nicolassavydigitalqalead/

  • 3 years and 11 months, Jun 2013 - Apr 2017

    Senior Consultant / Solution Manager

    Altran Switzerland & GxP Consulting

    Delivered QA, CSV, cleaning-validation and equipment-validation project leadership for pharmaceutical, biotechnology and medical-device clients operating in cGMP and ISO-regulated environments. please refer to my LinkedIn profile for updated information.

  • 1 year and 3 months, Mar 2012 - May 2013

    Team Leader Equipment & Statistics and Net Content manager

    Nestlé Nespresso SA

  • 3 years and 9 months, Jun 2008 - Feb 2012

    Senior Consultant

    CVO-Europe

    In Belgium for different well known Pharma groups

  • 5 years and 8 months, Oct 2002 - May 2008

    Validation Engineer

    Ceva Sante Animale

    in France

Ausbildung von Nicolas SAVY

  • Current 8 months, since Nov 2025

    Certificate in Artificial Intelligence in Pharma and Biotech

    Massachusetts Institute of Technology

  • 2022 - 2024

    SAFe Agilist 5 & 6

    scaled agile

  • 2012 - 2013

    Coaching Levels 1, 2 & 3

    Nestlé Center of Excellence

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

    ISQM Quality management

    BEM Management School

Sprachen

  • French

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    C1 (Fließend)

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