Regional Quality Documentation Senior Specialist (fixed-term)

Job title: Regional Quality Documentation Senior SpecialistLocation: Budapest, HungaryJob type: Fixed-term 1 year contract, full timeHybrid workingAbout The JobOur Team:Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines.Main ResponsibilitiesFocus on initiation of quality documents (QD) workflow management: Identify authors, applicable templates sharing, document change request (DCR) communication if applicable, draft generation in QualiPSO (ID, metadata creation), final draft cleanup before approval.Manage and monitor the documentation update process, with periodic review process, in support to local document governance.Participate to local document governance meetings.Coordinate and prevent gap assessment process from other non-standardized approach.Manage the creation and update of metadata, understand the applicability of the documents/stakeholders, challenge the stakeholders, & implement communication strategy based local doc governance.Support document change request (DCR) process – support monitoring DCR process including pre-assessment & support doc update according to CR process.Prevent Change Request process from other non-standardized approach.Support communication on Global Quality Document approval.ExperienceAbout youProfessional experience in documentation.At least 1 year experience in GxP environment.Soft SkillsProficient in problem-solving.Attention to detail, and good organizational skills.Ability to work collaboratively with cross-functional teams in a flexible and proactive manner.Strong analytical skills.Technical SkillsMicrosoft OfficeStrong analytical skills.Knowledge of Quality DMS,is an advantage.EducationBachelor’s or Master’s DegreeLanguagesExcellent English communication and writingProficiency in at least one of the listed languages: French, German, Italian, Spanish, Russian, Hungarian, Turkish.Why choose us?Bring the miracles of science to life alongside a supportive, future-focused team in an international work environmentWork from an "Office of the Year 2023" award winner with flexible home office policyEnjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impactTake good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leaveAn individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeksJoin a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)Pursue Progress. Discover Extraordinary.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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.At Sanofi, we provide equal opportunities to all regardless of race, color, 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!Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.#Sanofi #SanofiCareers #joinSanofi#jobopportunities #careeropportunities #sscjob#Sanofi_Budapest_Hub #Budapest#R&DnullPursue Progress. Discover Extraordinary.Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.