Freelancer profile translated to English.

Description

Industrial biology engineer with a specialized Master's degree in Quality Management, I have 12 years of experience in quality management within multinational pharmaceutical and logistics environments. I have held global positions, developing in-depth expertise in pharmaceutical industry quality standards, specifically EU-GDP regulations, as well as being an IRCA ISO 9001 lead auditor. Today, I am turning to quality consulting, where I leverage my know-how to support companies in their certification projects, audit/inspection preparation and follow-up, supplier qualification, implementation of Quality Management Systems (QMS), quality project management, and training to improve internal quality culture. My goal is to guide companies towards operational excellence and regulatory compliance.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent
Arabic
Native or bilingual

Workplace preferences

Can work on-site

Marseille (up to 50km), Lyon (up to 10km), Paris (up to 10km)

Ipsen Pharma
Quality Manager - Global Function
PHARMACEUTICALS INDUSTRY
December 2017 - January 2023 (5 years and 2 months)
Paris, France
Responsible for African and Middle Eastern countries (subsidiaries and distribution partners), EU (France, UK, Spain/Portugal, Germany, Italy, Ukraine) => over 25 distribution partners and 10 subsidiaries
• Responsible for subsidiaries and distribution partners: monitoring GxP activities in collaboration with the business through quality monitoring, mock audits, and contract negotiations
• Managing quality aspects during acquisitions, transfers, product launches, storage and distribution infrastructure launches, new subsidiaries
• Ensuring the deployment and local adherence to the global QMS (defining the roadmap and monitoring)
• Acting as the liaison point between subsidiaries and the global audit team: pre-assessment of GxP activities and support in establishing the global audit program through a risk-based approach
• Managing distribution partners: quality due diligence, re-evaluation, QTAs, annual assessment
• Managing customer complaints and temperature excursions
Key achievements: 100% of distribution partners with a signed QTA – Leading the project for the launch of a new distribution and storage warehouse from facility selection to obtaining the distribution license from local authorities – Supporting the launch of a new subsidiary in MEA
Ceva Logistics
QUALITY MANAGER - GLOBAL FUNCTION
LOGISTICS AND SUPPLY CHAIN
January 2023 - May 2025 (2 years and 3 months)
Marseille, France
• Team Management: 3 quality experts with direct reporting line
• Designing and deploying supplier quality governance
• Responsible for non-conformity governance, CAPA, customer complaints
• Responsible for harmonizing quality practices across all CEVA regions
• Defining Key Performance Indicators (KPIs) to monitor product/service quality
• Guiding the organization in a continuous improvement approach
• Project Management: implementation and deployment of an e-QMS, implementation of a digital solution to manage quality alerts
Key achievements: Leading the project for the redesign and harmonization of the customer complaint process / Improving the handling of key customer complaints / Comprehensive qualification of global critical suppliers from 0% to 75% according to a new qualification process / Deployment and implementation of the Intelex eQMS at global and regional levels as project manager.
Enterome
Quality Coordinator - Fixed-Term Contract
PHARMACEUTICALS INDUSTRY
September 2016 - September 2017 (1 year and 1 month)
Paris, France
• Implementation of an integrated quality system according to ISO 9001 and ISO 13485 standards
• Implementation of the ISO 9001 process approach and process mapping
• Facilitating a workshop with process owners to increase adherence to ISO 9001
Key achievements: Map of macro-processes and key operational processes – Creation of a risk management tool – 50% of the integrated QMS completed