Nassima Roy

Freelance Program Manager helping teams deliver strategic programs, from system deployment and PMO setup to change management and governance.

– Responsible of Portfolio centralization and management for internal projects and programs (Technology, Processes, People). – Prioritization and decision making to support Evotec's strategy. – Global project budget construction and monitoring. – Harmonization and standardization of Project Management practices. – Contribution to IT strategy design and implementation.

– Led IT program workstream for construction of J.POD® 2 commercial biomanufacturing facility. Budget: 5M€. – Oversaw implementation of core infrastructure, business and scientific applications (ERP, MES, CMMS, QMS, DMS, BMS, PAS). – Managed deployment of local IT services (e.g., meeting room equipment, helpdesk). – Oversaw GxP compliance through qualification and Computer System Validation (CSV).

– Drove a cultural change project through the implementation of risk & opportunity management in a Sanofi department specialized in API third-party sales for pharmaceutical companies (today known as EUROAPI). – Designed for Finance, a Risk & Opportunity Assessment tool, integrated in forecasts exercises, for Budget accuracy. – Defined with Supply Chain, a process for identification & calculation of API's opportunity stocks, for business development. – Designed Strategic Risk & Opportunity Management methodology & tool, as the new golden standard for Sanofi Active Ingredient Solutions end-to-end activities, including: – Business (API Sales), Supply Chain and Quality & Regulatory activities – Industrial Operations including Development activities (3 sites) – Contract Development Manufacturing & Business development. – Deployed end-to-end Strategic Risk & Opportunity Management mindset and tools through training, change management and transversal cooperation of multicultural teams, spread throughout the world. – Contributed to the implementation of Business Continuity Strategy on industrial perimeter.

Project Management: – Leader of a project of risk management process harmonization and software development. – Defined the project strategy and the project team organization. – Designed of the user requirements and technical specifications. – Organized the request for information and call for tender for software acquisition. Risk Management: – Deployed a risk management methodology to the whole portfolio of new drug development and launch, through training and coaching of project teams (France, USA, Germany, Japan). – Designed methodology and tools to assess the maturity of a project risk management process and its performance. – Contributed to the design of an extension of the methodology to Due Diligence and to Product Risk Management, and development of the pilots.

– Deployment of a risk management methodology to the whole portfolio of new drug development and launch (Chemistry, Manufacturing and Control). – Training, coaching of project teams (France, USA, Germany, Japan). – Participation to the design of an extension of the methodology to Product Risk Management, and development of the pilots. – Improvement of the risk management tools. – Design of methodology and tools to assess the maturity of a project risk management process and its performance. – Contribution to the creation of the roadmap for the Project Risk Management Office.

– Management of solution production for the high-throughput screening, of high priority compounds out of current drug discovery efforts. – Quality control of screening solution (using LC-MS and NMR), decision (acceptance or rejection) and publication of quality reports. – Chemical registration of compounds in the Novartis database and management of controlled substances. – Training of newcomers and management of a team of 10 interns. – Use of M-Nova, operation on robotics stations (Tecan, ASP)