Freelancer profile translated to English.
Back to original languageAbout François-Michel
With over 20 years of experience as an IT and Information Systems engineer, and 15 years specializing in consulting for the pharmaceutical and cosmetic industries, I have developed essential skills in team leadership, governance, and organization throughout my career. My specialty is my natural ability to lead and establish strong partnerships.
Over the years, I have gained expertise in the following areas:
• Structuring, promoting, and managing complex Information Systems and Data projects/programs
• Excellent communication
• Change management
• Effective coordination of project stakeholders, including internationally
• Building strong stakeholder relationships
• Developing and maintaining supplier partnerships
• In-depth knowledge of specific regulations for pharmaceutical and cosmetic industry systems (GxP, data protection).
My approach aims to achieve results that align with your company's strategic vision. I am a dynamic and confident communicator, motivated to use my technical, organizational, and relational skills to contribute to your company's success.
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 30km), Dijon (up to 30km), Lyon (up to 30km)
Experience
- Pierre FabreProject/Program ManagerPHARMACEUTICALS INDUSTRYSeptember 2018 - Today (7 years and 9 months)Boulogne-Billancourt, FranceManagement of various strategic IS and Data projects/programs for the pharmaceutical and dermocosmetic entities of the Pierre Fabre group:• RIM/IDMP Program (Veeva Vault)• PV/CV IS Upgrade (Oracle Argus)• Clinical Data Platform• Dermocosmetic Regulatory IS (Veeva Regulatory One)Strategic Consulting:• Management of pre-scoping and scoping phases• Implementation of a global project/program strategy• Engagement and obtaining agreement from sponsors and senior management• Structuring of projects/programs (working groups, governance)• Supplier selection (RFI, RFP) in agreement with relevant entities (Business, IT, Purchasing, Legal)• Sizing and alignment of deliverables according to stakeholder strategies and expectationsOperational project/program management:• Budget management, planning, risk management, delivery monitoring• Leading strategic committees, steering committees, kick-off meetings, periodic team meetings, and ad hoc meetings (supplier demos, CRP, workshops)• Maintaining project stakeholder alignment and engagement, facilitating decision-making and implementing an effective escalation management process
- GaldermaProject DirectorPHARMACEUTICALS INDUSTRYJune 2017 - August 2018 (1 year and 3 months)Courbevoie, FranceUpgrade of the Safety/Pharmacovigilance system:• Management of the upgrade of Galderma's Safety/Pharmacovigilance IS based on ARISg, including internationally (USA, Sweden, Brazil, Germany, Japan, India)• Coordination of stakeholders, including sponsors, business leaders, key users, IT teams, and suppliers• Management of budgets, planning, risk assessment and monitoring, and project KPIs• Organization of key meetings (steering committees, kick-off meetings, Core Team meetings, working group meetings, workshops)• Management of the implementation and validation of the GxP solution according to industry best practices• Streamlining and improving reporting processes using Agile/SCRUM methodologyCompliance with Nestlé Technical Standards and Security Patching:• Supervision of the alignment of Galderma's Competence Centers with Nestlé Technical Standards• Organization of update campaigns to enhance security and reduce vulnerabilities• Definition of the strategy and management of the implementation of automatic security patching• Implementation of a monitoring system to track and address remaining security vulnerabilities
- GSKQA IT Compliance Project ManagerPHARMACEUTICALS INDUSTRYSeptember 2015 - May 2017 (1 year and 9 months)Rixensart, BelgiumQA Oversight within the Novartis Vaccines Integration program:• Key role in the Novartis Vaccines integration program: QA oversight for all 35 R&D IT projects within the program• Consulting and guidance to various business units: Clinical, Regulatory Affairs, and Discovery• Oversight of the validation of critical IT and analytical systems, including integration, lift & shift, and contract transfer projects• Creation of Key Performance Indicators (KPIs), reports, and a risk and issue management methodology• Conduct of a transverse risk analysis associated with data migration for R&D systems• Contribution to the development and maintenance of the program's Master Validation Plan• Review of R&D project validation documentation to ensure alignment with Quality and VSI processesQA Oversight within the Novartis Vaccines Integration program:• Key role in the Novartis Vaccines integration program: QA oversight for all 35 R&D IT projects within the program• Consulting and guidance to various business units: Clinical, Regulatory Affairs, and Discovery• Oversight of the validation of critical IT and analytical systems, including integration, lift & shift, and contract transfer projects• Creation of Key Performance Indicators (KPIs), reports, and a risk and issue management methodology• Conduct of a transverse risk analysis associated with data migration for R&D systems• Contribution to the development and maintenance of the program's Master Validation Plan• Review of R&D project validation documentation to ensure alignment with Quality and VSI processes
Recommendations
Be the first to recommend François-Michel
Help this freelancer shine by sharing your experience working together.
These freelancer profiles also match your criteria
Agatha Frydrych
Backend Java Software Engineer
4.7
(3)
2
Baptiste Duhen
Fullstack developer
4.6
(4)
5
Amed Hamou
Senior Lead Developer
4
(2)
7
Audrey Champion
Web developer
4.3
(3)
4
Education
- Engineer, Information Systems and Computer Science OptionCNAM2009
- Professional Bachelor's Degree in Information and Decision Systems Analyst DesignerConservatoire National des Arts et Métiers2004
Certifications
- ITIL FoundationAPM Group2009
- Prince 2 PractitionerAPM Group2010