
Mamadou B.
Strategic Advisor | Digital Transformation & IT Se
1 recommandation
Salaire / Taux journalier
1 personne recommande
47600 Francescas, France
Freelance, ouvert au CDI
Expertises
Langues
À propos
Introduction
I help organizations navigate digital transformation and IT services strategy, with a strong focus on regulated industries such as life sciences. With a background in Quality Systems (QMS), Veeva Vault, and compliance-driven environments (GxP), I operate at the intersection of technology, business, and regulation. I bring a strategic perspective on: • How AI is reshaping IT services, outsourcing models, and delivery structures • Vendor positioning, selection, and performance in transformation programs • Optimization of digital initiatives in complex, regulated environments I have worked across global organizations, collaborating with IT, Quality, and business stakeholders to drive large-scale transformation programs and improve operational efficiency. In parallel, I am the Managing Director of Oralis Invest, where I focus on bridging capital, technology, and strategic opportunities — particularly between international investors and high-potential projects. I am open to expert consultations on: • IT services trends and vendor strategy • AI impact on digital transformation and delivery models • Digital transformation in regulated industries I only share high-level, non-confidential insights based on market observations and professional experience. 📌 Expertise QMS Digital Transformation (Veeva Vault, CRM, CMS) Business Process Optimization & Governance CSV – GxP Compliance / Validation Strategy Global Stakeholder Engagement Continuous Improvement & Lean mindset Investment & Capital Advisory (Oralis Invest)
Expérience de travail
Managing Director
Oralis InvestFreelance
nov. 2025 - Présent
1 an
Dubaï - Émirats arabes unis
ORALIS INVEST Managing Director – Capital, Trade & Technology Advisory Nov 2025 – Present · Dubai, UAE · Remote Oralis Invest is a strategic advisory firm focused on bridging capital, technology, and international business opportunities. Key areas of focus: • Capital & Investment Advisory – Supporting large-scale projects in structuring and investor outreach (GCC, Africa, Europe) • Digital & Technology Consulting – Advising on digital transformation, IT strategy, and compliance-driven systems • Brokerage & Trade Facilitation – Facilitating international transactions and strategic partnerships I work at the intersection of investment, technology, and cross-border opportunities, with a strong focus on high-impact projects. Business Model: Partnership-based deal facilitation & capital bridging strategies
SanofiFreelance
sept. 2020 - Présent
6 ans 2 mois
69340 Francheville, France
Consultant, Business System Owner - QMS & Digital Transformation/Global Quality
déc. 2021 - Présent
4 ans 11 mois
69340 Francheville, France
•Consultant – Digital Transformation & Quality Systems (Global Quality) Contributed to large-scale digital transformation initiatives within Global Quality, with a focus on QMS modernization and Veeva Vault implementation. • Collaborated with cross-functional stakeholders (IT, Quality, Business) to define requirements and optimize workflows • Gained strong exposure to IT service delivery models and vendor collaboration in regulated environments • Supported the implementation of compliant digital solutions (GxP) across global teams • Participated in validation activities (CSV) and ensured alignment with regulatory expectations This role provided a strong perspective on how IT services, vendors, and digital strategies operate in complex, compliance-driven environments. Veeva Vault configuration, document lifecycles, workflows, security settings, metadata management, and API/integration support. Skilled in QualityDocs, QTP, Audit and Inspection Auditor qualification and Vault administration in GxP-regulated environments. Strong expertise in: • Veeva Vault configuration & customization • Lifecycles, workflows, permission sets & document types • API integrations, troubleshooting & migration support • Vault Loader, SDK basics & validation activities • Quarterly release assessment & regression testing • Regulatory compliance (21 CFR Part 11, GxP) • Issue analysis, root cause investigation & production support Technologies & Methods Global Stakeholder Management IT Services Strategy Digital Transformation Artificial Intelligence (AI) Vendor Management Outsourcing Strategy Life Sciences GxP
Consultant, Chef de projet Lean Six Sigma | Data integrity
sept. 2020 - déc. 2021
1 an 4 mois
Vétheuil, France
Consultant – Lean Six Sigma Project Manager & Data Integrity Sep 2020 – Nov 2021 · 1 yr 3 mos Vitry-sur-Seine, France · Hybrid Supported manufacturing operations within the DSM-B (Drug Substance Manufacturing – Biologics) department, driving continuous improvement initiatives and data integrity performance across GxP processes. Key Achievements & Responsibilities • Led a Lean Six Sigma DMAIC deployment to improve data integrity compliance • Enhanced and formalized quality processes and performance indicators • Conducted root cause analysis and supported process improvement action plans • Facilitated improvement workshops and training sessions (Lean mindset adoption) • Ensured efficient coordination and communication with project sponsors • Performed data analytics to drive operational decisions and improvements • Planned activities and authored progress reports & return-on-investment assessments Project Optimization of a data integrity control process using Lean Six Sigma DMAIC methodology on a biologics R&D site. Skills & Methods Lean Manufacturing · DMAIC · Data Integrity · Project Management · KPIs · Continuous Improvement
Document Control Manager
Parfums Christian Dior
sept. 2018 - oct. 2020
2 ans 2 mois
On-site
• Document Control Manager – Quality Systems Sep 2018 – Sep 2020 · 2 yrs 1 mo On-site Managed the Electronic Document Management System (EDMS) for Dior Cosmetics operations, ensuring compliance with GMP (ISO 22716) and FDA requirements and driving continuous improvement of Quality documentation workflows. Key Responsibilities & Achievements • Led the EDMS enhancement and modernization to improve documentation efficiency • Conducted functional evaluation of the document management system and process governance • Drove the project to transition to a new document control system • Performed GMP compliance audits on production activities • Conducted training sessions on Cosmetic GMP and Document Control best practices • Supported EDMS local champions and monitored system adoption across users • Managed review and approval cycles through digital workflows • Prepared inspection readiness and supported auditors during Regulatory inspections (Front Room execution & QMS responses) Skills & Tools Document Control · EDMS (OpenText) · GMP Cosmetics · Training & Change Management · Workflow Optimization
Quality Technician
Air Liquide Medical Systems
avr. 2017 - août 2018
1 an 5 mois
92160 Antony, France
• Quality Technician – Manufacturing & Compliance Support Apr 2017 – Aug 2018 · 1 yr 5 mos Antony, France Supported medical devices manufacturing operations by ensuring product compliance, effective control plan execution, and continuous improvement of Quality processes. Key Responsibilities & Achievements • Performed DHR (Device History Record) review and release to support product batch disposition • Created and updated inspection plans and control ranges in the LUG3 system • Prepared inspection reports and documented nonconformities with follow-up actions • Engaged with suppliers to drive corrections, returns, and compensations where required • Analyzed inspection and production data to identify improvement opportunities • Provided Quality support to production teams on the shopfloor • Led NC management from root-cause investigation to corrective actions follow-up • Conducted GMP audits on operational activities • Facilitated problem-solving routines using 5 Whys, Ishikawa diagrams & 8D methodology Skills & Methods Medical Devices · DHR Release · Nonconformity Management · Supplier Quality · Problem Solving (5P, 8D) · GMP · Data Analysis
Quality Manager
Groupe Trouillet
mai 2016 - mai 2017
1 an 1 mois
Saint-Jean-de-Braye, France
• Quality Manager – Manufacturing Operations May 2016 – Apr 2017 · 1 yr Saint-Jean-de-Braye, France Led Quality Assurance initiatives within industrial manufacturing, focusing on nonconformity management, process improvement, and team engagement. Key Responsibilities & Contributions • Oversaw nonconformity handling and corrective actions to support production performance • Recorded, tracked and analyzed NC indicators through dedicated monitoring dashboards • Performed workstation and process audits to assess operational compliance and efficiency • Implemented CAPA programs and ensured follow-up effectiveness • Trained and coached production teams on Quality culture & improvement actions • Developed work instructions, process mapping, and documentation to strengthen QMS practices • Established and executed action plans following UTAC regulatory audit recommendations Skills & Methods Industrial Quality · CAPA · Process Audits · NC Management · Team Training & Engagement
Formation
Université Rennes 2
Arts et Métiers - École Nationale Supérieure d'Arts et Métiers
Mastère spécialisé , Manager de la Qualité, management de la qualité
Résultat : Mention très honorable
Module A : fondamentaux de la Qualité et Certification Module B : lean Management et Six Sigma Module C : management de Projet par la Qualité Module D : management des Risques et Outils Qualité Module E : management des Hommes et Communication Module F : applications dans les domaines de la Santé et des Services Module G : management et conduite de projet professionnel
Institut d'études politiques de Rennes
Résultat : Mention Assez Bien
IFOCOP
Pack Qualité, Qualité hygiene securité environnement
Licences et certifications
Certification de compétences et connaissances réglementaires sur les bonnes pratiques de fabrication du médicament TOSA VisaePharma
Délivré le : janv. 2020
Application de la cotation fonctionnelle et du langage ISO/GPS, ingénieure mécanique
Délivré le : juin 2017
Certification d'Auditeur de système de management
Délivré le : sept. 2015