Dominique Thierry

Global Excellence Director I Executive Quality Leader I Board Advisor I Life Sciences

Salaire / Taux journalier

Fribourg, Suisse

Freelance, ouvert au CDI

Peut venir sur site

Expertises

Conformité réglementaireTest & QALean ManagementGestion de la supply chainNégociationService clientIAAmélioration des processusFormationPrévisions

Langues

Français (Maternelle)Anglais (Courant)EspagnolAllemand

À propos

Introduction

Organizational Excellence Leader, with proven ability to develop and drive performant project teams, to successfully deliver world-class projects in global organizations, to implement changes and innovative solutions, while continuously focusing on Patient safety and drug quality, efficacy, and integrity, all along the product life cycle. Design, development and execution of operational & strategic projects to support business and organisational strategies. Budgets ranking from 90 KCHF to 2000 KCHF. Managed project teams from 4 to 30 headcounts. Implementation of organizational in distribution & manufacturing environments – Pharma, Biotech, Medtech. Managed and developed global & regional operational teams. In-depth experience in Good Distribution Practice, global Supply Chains readiness and compliance, and worldwide distribution of pharmaceutical products. Regulatory Compliance experience consistent with worldwide regulatory requirements (US, EMEA, APAC, LATAM) – Inspection readiness – Complaints/Adverse Events/FSCA management, Post Market Surveillance management. Change Control, CAPA management. Inspections, audits, regulatory authority requirements management.

Liens

Expérience de travail

Principal Senior Consultant Quality Compliance Regulatory Affairs

CAI

juin 2022 - mai 2025

3 ans

Genève, Suisse

– QCR - GMP Audits - QMS Gap Assessments and improvements - PRRC-RP ad-interim positions – Development of the QMS for a new biotech PEL - Regulatory Inspections prep and lead. – Operational Readiness : PM - Development of performance dashboards for a biomanufacturing plant – CQV: PM - Development of URS (bilingual EN-DE) for new facilities & equipment of a biotech company – Business Continuity: PM - Development of the business continuity plan of a new manufacturing site

Director Global Quality Assurance, Medical Devices

HOYA Surgical Optics

janv. 2021 - juin 2022

1 an 6 mois

Francfort-sur-le-Main, Allemagne

– Supporting the VP QA in development and implementation of the overall Global Quality management Strategy – Ensuring compliance of distributors and suppliers with regulatory standards and with Hoya requirements – Leading the HSO regional and global QA teams – Collaborating with the area heads to improve the HSO QMS – Supporting the HSO Sales & Marketing organizations regarding quality activities.

Senior QA Consultant - GMP-GDP - Pharmaceuticals & Medical Devices

Santen

déc. 2017 - déc. 2020

3 ans 1 mois

Geneva Area, Switzerland

– Medicinal Products - Medical Devices – Regulatory standards: EU GMP-GDP Guidelines - ICHQ9 & 10 - ISO 13485 EU Medical Device Regulations (MDR) - FDA 21 CFR - WHO Guidelines & Technical Reports – Veeva Vault Quality Documentation (SOP, WI, Quality Manual, SMF) – Supply Chain Achievements: – Quality System & Quality Documentation design, development and implementation – Good Distribution Practices Training: design, development and roll out (EMEA - ASIA & JAPAN) – Continuous Improvement: facilitation - Lean Management & Belbin Team Roles implementation – Regulatory inspections readiness in EMEA branches: support and coordination of the documentation - Wholesale Distribution Authorization (WDA) and Manufacturer/Importer Authorization (MIA)

Visiting Lecturer

HEG - Genève

sept. 2014 - févr. 2017

2 ans 6 mois

Geneva Area, Switzerland

– Digital Transformation for Business | International Business Management Organisation | Economie d'entreprise – Conflict Management & Negotiation | International Business Management – Business Excellence | Management Durable – Gestion de la Santé | Management Durable

Senior Consultant Pharmaceuticals

Independant

oct. 2012 - janv. 2017

4 ans 4 mois

Geneva Area, Switzerland

– Operational Excellence - Project Management - Process Improvement – GMP-GDP Compliance & Audits – Regulatory standards: EU GMP– GDP – FDA – WHO – ICH - ISO – Quality Documentation Management: quality manual, procedures, regulatory documents. – QA Management - Suppliers' qualification. GMP-GDP Audits – QA Monitoring: Key Performance Indicators - Metrics Design & Management – Public Health Advocacy - AMR Control

EMEA Communication Advisor, Chemicals

DuPont

mai 2011 - oct. 2012

1 an 6 mois

– Training design & development - Communication program design & development - campaigns management - EMEA training package coordination. – Newsletters and releases editing. SHE Conferences organisation & management. – Safety, Health, Environment – Communication

Senior Management Associate Consultant

Optimis

févr. 2009 - avr. 2011

2 ans 3 mois

Lausanne Area, Switzerland

– Organizational development / HR systems / Training program design / Capabilities framework design / Quality Systems management & implementation / Communication program and tools design & development / Supply chain & procurement improvement / Multinational companies & international organizations.

Corporate QA Auditor MBA

International Committee of the Red Cross

janv. 2007 - mars 2008

1 an 3 mois

– Quality Audit - GMP - GDP - WHO - ICH - Quality Assurance - Quality System Management - Drugs - Pharmaceutical - Medical - Supply Chain - Training - Vaccines, Biological products, Sterile Products, Medicinal Products, Medical Devices. – In charge of : – managing and assessing worldwide drugs suppliers according to ICRC & WHO quality standards; – prospecting for new sources and participating in the design of a corporate supply policy for medical products and drugs; – defining and implementing an ICRC QA system for the supplying of drugs.

Head of Production - Marketing & Communication

International Committee of the Red Cross

janv. 2004 - déc. 2006

3 ans

– Communication strategy - Project design - Project management - Training - Survey management – Strategic communications management: 20 people managed – Design & development of communication strategy, plans & budget – Strategic design & deployment of institutional web communication - corporate , field and decentralized multilingual website - – Team Management - Staff of 20 people, all of them were communication experts (web, publications, audio & visual...) – Digital communications – Publications – Multimedia – Audiovisual

Operations Manager

Richemont

mars 1998 - déc. 2000

2 ans 10 mois

Fribourg, Suisse

– International Supply Chain Management - Business Planning & Operations - Negotiation - Customers Service. – Purchasing, planning, forecasting, ordering, stock management, customer service & quality management - Luxury goods – Int. Operations Management of all Cartier Accessories : Perfumes, Leather goods, Glasses, Lighters, Art de la Table, Scarves, Gifts, Pens, ...etc. – Managed a team of 19 employees, a portfolio of 80 suppliers.

Quality Manager - Commercial Logistics

L'Oréal

juin 1996 - mars 1998

1 an 10 mois

76 Karlsruhe, Allemagne

– Planning, coordination and control of new logistic/supply chain activities transferred from Frankfurt to Karlsruhe, within the acquisition of a new brand: Jade. Managed & coordinated the x-stakeholders including the infrastructures & equipment's suppliers, the steering committee, the staff and line managers - 75 people. Implemented the corporate commercial quality system in 3 business units: Produits Publics, Garnier-Jade and Coiffure.

Quality System Manager - Commercial Logistics

L'Oréal

janv. 1991 - mai 1996

5 ans 5 mois

Paris, France

– Designed, developed and installed the quality system and programme of the supply chain, distribution & retail network all over the world. Formalized the corporate guidelines of the quality system, developed measurements software, increased the reliability of the supply chain processes, improved the commercialization processes through continuous improvement. Deployed the corporate operational excellence approach through worldwide business operations. Trained the business units' executives to facilitate the adoption of the new quality mindset throughout regional commercial networks and customer service. Drove the overall improvement program at corporate level. Achieved 12 audits in business units located in Asia and Europe. Managed 3 engineers. Pilot site: Lancôme France, certified ISO 9002 in 1996.


Formation

University of Strasbourg

Doctor of Pharmacy, Pharmaceutical Sciences

IPI Faculty of Pharmacy, Montpellier, France

DESS - Masters, Mathematical Statistics and Probability, Pharmaceutical manufacturing

University of Geneva

EMBA, Business Administration and Management, General

2003 - 2005

2 ans 1 mois


Licences et certifications

Statistical Process Control

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Pharmaceutical GMP Professional

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Managing Globally

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EFQM Assessor

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Certifié par EFQM

Transitioning from Manager to Leader

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