Digital Quality, Process and Tools LEAD

  • Barcelona
  • Sanofi
Our Team:Our team is engaged in designing and delivering Digital Tech Services for all CHC worldwide.We deliver our solutions in a highly competitive market answering FMCH needs and sometimes supporting highly regulated environments (GxP, SoX and other regional and local regulations).Our team operates in an international context, serving all markets in most of the countries around the world.To reach our goals we have organized our model around 6 main pillars:Enterprise architectureInfrastructureCyber SecurityOperationsIntegrationStrategy & operationsMain responsibilities The Quality, process and tools expert is a key member of the CHC Digital team providing mission-critical Quality and Compliance expertise. The incumbent is the point of contact and Quality Partner for the Digital CHC area; she/he provides end-to-end Quality & Compliance oversight by ensuring the delivery of Quality Services related to Project & Application Support, including process and tools, and Quality Management, including training, documentation, and performance.This position covers an exciting and innovative CHC business scope with a variety of critical Digital/IT solutions built on both established and emerging technologies.The position provides an opportunity to work in a dynamic, international Quality Operations team, while at the same time gaining experience in CHC through contribution to a variety of projects and system lifecycle activities.A key pillaris to continue with the adaption of the Agile Methodology by developing new product development processes combining both Agile and GxP requirements taking advantage of Automation and DevOps techniques.To improve performance of Applications teams, scrum masters, product owners and overall product management by providing a high-quality software delivery suite that empower collaboration and automation.As we extend the Agile organization and grow in maturity, we must combine Agile and GxP requirements to deliver the Digital solutions faster at scale.The priority areas of focus are:Promote Agile software development rituals to standardize across teams the best practices including the right usage of Jira, Confluence, Gitlab/GitHub in GxP compliancy. Deliver templates & features to help POD & Teams in their activities.The role will require strong transformation and leadership in relation to:Digital stakeholders: Quality Operations Leadership teamDigital Units Leadership team membersDigital Units Service/Domain managers and Application teamsStakeholders outside of Digital Organization: Global Quality/Business Quality Internal Control Internal Audit Corporate Risk ManagementData Privacy OfficeExternal Stakeholders: Regulatory Agency inspectors External auditorsSuppliers / Service ProvidersFormal Education and Experience requiredBachelor’s degree in a scientific, engineering or IT discipline10+ years of experience IT or Digital teams ideally on domains like enterprise software deployment or software development and significant experiencein Quality Management, compliance (GxP, SOX, Data Privacy) or Information Technology contributing to regulated projects or system lifecycle activities.Technical backgroundrequiredProven experience in Agile adoption as well as software development lifecycle process.Product and Software development experience.Broad understanding of information technology solutions, theory and principles and their application to multiple areas of specialtyBroad, in-depth knowledge of Quality Management, industry standards, regulations (GxP, SOX, Data Privacy, etc.), and trendsVery good understanding of IT life-cycle processes and required controls to ensure reliability and compliance ofComputerized Systems and services (project methodology, application support and maintenance, ITIL processes, operational activities.)Validation of Computerized Systems in a GxP environmentApplication of Agile and Lean practices to System Lifecycle activities in a regulated environment Use of Life Cycle management tools, esp. Jira/Confluence and GitHub.Support the implementation of new technologies such as SaaS systems, RPA and Machine Learning in a regulated context.Established experience with project management programs, SCRUM, and different variants of AGILE techniques are also expected, along with familiarity with code management and Continuous Integration/Delivery Implementation (CI/DI), testing, DevOps and Automation.Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our and check out our Diversity Equity and Inclusion actions at ! At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.