Digital Quality Compliance and Risks Expert

At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives' now and for the generations to come.    In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees' mission and operate responsibly from both a social and environmental point of view.   Everything we do is centered around people's interests – our consumers, our customers, healthcare professionals, and our employees – across the world.    We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.   We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.   As Digital Compliance and Risks Expert, you will join an international and dynamic team, that is engaged in designing and delivering Digital Tech Services. In this role you will deliver mission-critical Quality and Compliance expertise for all Consumer Health Care (CHC) worldwide. The team delivers these solutions and services in a highly competitive market, responding to Fast Moving Consumer Healtcare (FMCH) needs, and are sometimes supporting highly regulated environments (GxP, SoX and other regional and local regulations). The role focuses on an exciting and innovative CHC business scope with a variety of critical Digital/IT solutions built on both established and emerging technologies. Because of this, we are looking for someone who has a broad understanding of IT solutions, theory, principles and their application to multiple areas of specialty. As a team member, you will be working in an international context where you are the point of contact and Quality Partner for the Digital CHC area where you will be interfacing with internal stakeholders (both digital and non-digital) as well as external stakeholders (such as Regulatory Agency inspectors, external auditors, service providers, etc.). You will need to provide end-to-end Quality & Compliance oversight by ensuring the delivery of Quality Services related to Third Party Quality Management, Audit & Inspection Support, and Risk Management. You will identify and assess risks related to regulations vs. Digital and take the required actions to mitigate or accept them. As such, you will be the connecting link between IT and the business, translating the relevant external regulations into digital aspects. In this role, you'll have the challenge to shape Digital Quality processes & procedures that will allow our company to stay compliant with applicable regulations in the long run, while also keeping us focused on our customers, as a fast-moving company. You will ensure that the Digital quality processes & procedures are as simple & efficient as possible. An in-depth knowledge of Quality Management, industry standards, regulation (GxP, SOX, Data Privacy, etc.) and trends is thus required as well as a good working knowledge of English. Any other language skill is a big plus. We are looking for a candidate with a very good understanding of IT life-cycle processes and required controls to ensure reliability and compliance of Computerised Systems and services (e.g. project methodology, ITIL, applications support and maintenance, operational activities, etc.) because they will be contributing to a variety of projects and system lifecycle activities. E.g. Setting up a new GxP-compliant application in the landscape and ensuring relevant documents are provided, supported external or internal audit as a Digital SPoC coordinating with other Digital stakeholders. Additionally, you'll need experience with validation of Computerized Systems in a GxP environment, as well as the use of Life Cycle management tools (esp. Jira/Confluence and HP ALM). In summary, our ideal candidate has: A Bachelor's degree in a scientific, engineering or IT field (or equivalent by experience), Over 5 years of experience in Quality Management, compliance (GxP, SOX, Data Privacy) or IT contributing to regulated projects or system lifecycle activities, Good English language skills, any other language is a plus, Broad understanding of information technology solutions, theory and principles and their application to multiple areas of specialty.  Broad, in-depth knowledge of Quality Management, industry standards, regulations (GxP, SOX, Data Privacy, etc.), and trends  Very good understanding of IT life-cycle processes and required controls to ensure reliability and compliance of Computerized Systems and services (project methodology, application support and maintenance, ITIL processes, operational activities...)   Validation of Computerized Systems in a GxP environment  Application of Agile and Lean practices to System Lifecycle activities in a regulated environment   Use of Life Cycle management tools, esp. Jira/Confluence and HP ALM  If this sounds like you, don't wait any longer! Get in touch, apply for the role, and be the first to join this new team at the heart of our CHC business! Pursue progress, discover extraordinary! 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  ALL IN video  and check out our Diversity Equity and Inclusion actions at  sanofi.com ! Pursue progress, discover extraordinary 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, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Fecha publicación: Hace 21 días Ubicación: Barcelona (España) Área funcional: Otros Sector empresa: Otros

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