Our Team: The Digital Quality Lead - Manufacturing Planning is a key role in the Digital Quality Operations team. This team ensures that Digital projects, products, processes, and services are delivered with the right level of quality and in compliance with Sanofi and regulatory expectations. Within this team, you will be able to work in a dynamic, international environment gaining experience across different business areas in Industrial through contribution to a variety of projects and system lifecycle activities.
Main Responsibilities:Ensuring compliance during Business Digital Solution Lifecycle (Development-Delivery & Maintenance).Define validation/qualification strategy and provide advice, guidance, and approval on validation activities in collaboration with Business Quality and project teams following a risk-based approach.Provide guidance and oversight for the management of CAPA related to the supported systems.Support Risk Management through identification, characterization, and development of mitigation plans, in collaboration with Digital Units and other stakeholders.Partner with Digital Product, Program, Development, and Technology teams in Digital Industrial to ensure Quality by Design in every project and throughout the system and technology life cycle to ensure Digital products and technologies are fit for their intended use and meet - where applicable - regulatory requirements.Support the Digital Organization during audits and inspections.Collaborate with Business System owners, Business Quality, and Solution Center representatives to prepare for regulatory inspections and internal audits, respond to questions, and address findings through corrective/preventive action plans to improve compliance and effectiveness of the Quality Management System.Contribute to the continuous improvement of the integrated Digital Quality framework to enable agile ways of working and the implementation of new technologies while ensuring compliance with all applicable regulations (GxP, Sarbanes-Oxley, etc.) and standards.About You:Experience: Computerized Systems compliance in regulated environments (GxP and SoX) such as Pharmaceutical/biotechnology industry in a global, cross-functional, multi-national environment.Soft Skills: Demonstrated leadership and ability to effectively influence and make decisions; strong problem solving, decision making, transversal collaboration, and communication skills; intermediate change management skills.Technical Skills: Advanced knowledge of Risk Management, Project & Application management, compliance of computerized systems (e.g., GxP, SOX); understanding of Digital solutions in Pharmaceutical and experience with industrial Manufacturing processes is a differential; working knowledge of information security to collaborate with the security officer.Education: Life science, Quality, computer science or related scientific or technical discipline. Ability to understand Digital Products in Pharmaceutical environment.Language: Excellent written and oral communication in English, including ability to effectively educate various audiences on quality and compliance topics.Pursue Progress. Discover Extraordinary. Own your future. Make your move!
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