In charge of the quality processes (training, procedural management, quality events, archiving), data and computerized systems (Veeva, SAP, LIMS,...) of the fast growing company, I also cover the data integrity and transverse quality projects for the company, as well as regulatory intelligence. Lastly I implemented a continuous improvement and quality KPIs corporate oversight. As business owner for the Veeva Vault Quality platform, while ensuring an efficient and quick rollout of the platform over the past years, there is a strategic dimension in thinking and anticipating the quality processes for supporting the huge potential of the product pipeline, whether from a process, people or tool standpoint.

Centrally, I was in charge of actively driving standardization in the quality oversight activities for all lifecycle activities for Novartis GxP computerized systems. In continuation with my previous role, we were now in the execution phase of overall alignment program for Novartis, enabling consistent and pertinent GxP CSV requirements implementation, and efficient QA CSV operational model across Novartis. I led as well the group in charge of the QA support for IT operations, architecture and infrastructure services.

At Corporate level, I acted as the bridging GxP/ pharma regulatory agent between the Novartis QA and IGM/IT organizations. The large scope of this mission covered the alignment of the project and operational processes, the organizational impact, as well as the consistent GxP IT knowledge spread in Novartis organizations. I identified the most relevant and I aligned risk-based strategy for GxP IT systems and processes (SAP Quality Mngt, SAP Material mngt, Electronic Doc mngt, training...), working with the different organizations for ensuring effective implementation modalities in procedural, training, audit and 3rd party areas. This role required high influencing approaches and ability to deliver message to senior management.

This was a position with a double level of responsibilities: First tactical, for ensuring the divisional systems and projects are implemented on time and with the adequate level of quality and CSV compliance.Second is strategic for developing the vision for my QA department, while taking in account the Data Integrity aspects of the business as well as the paperless landscape and ambitions in pharmaceutical industry. For Vaccines & Diagnostics division, scoping TechOps, IT, Clinical and Development divisional activities : - I led the sites (UK, Germany, Italy, USA) and global E-Compliance managers to ensure that all aspects of global and local computerized systems comply with GxP regulatory requirements and internal Quality Manual requirements- I chaired the Divisional Computerized Systems Validation Committee, and the related improvement projects (SAP data flow, procedural and training management, automated testing, identity management, etc...)- I developed a network with Group CSV compliance representatives and develop the future QAECompliance vision.

I founded a restaurant on my free-time : building selection and complete refurbishment, project planning, administrative creation and maintenance, building transformation (either with external companies I selected or self-made), regulatory requirements fullfilment (food safety, environment and safety, tax and company management), logistical management and customer care.

On French sterile manufacturing site, I was leading a team in charge of :- compliance management (including CSV and Engineering)- Regulatory affairs management- audit management- SOP managementI acquired the experience of diverse QA compliance topics, especially the understanding of the complex regulatory filings expectations in pharmaceutical industry.

In charge of a 50 persons knife manufactury, I was managing and making decision for every steps of the production process : steel supply, manufacturing and scheduling, packaging and distribution. Out of pharmaceutical industry, I experimented there the demanding business of cutlery goods, where costs must be as low as possible while maintaining high quality. Daily direct interactions with customers led me to develop robust complaint management skills.

On green plant project (sterile new dosage product), I was the leader for Clean In Place and Steam In Place automated systems implementation (equipments + automation qualification, process validation). I acquired there an excellent knowledge of automation and IT set up in correlation with sterile production processes.

As a production supervisor, I was there in charge of 2 manufacturing and packaging lines for pharmaceutical dry forms. That was a fantastic management experience, and the opportunity to learn high reactivity on the shopfloor and to experiment business delivery pressure.

In this first industrial experience in pharmaceutical area, I discovered the dry forms manufacturing and packaging business, and experimented successfully how to improve processes by applying analysis tools (FMEA, statistical process control).