Requirements: English
Company: Sanofi EU
Region: Budapest , Budapest
- Job title: Quality Document Manager
- Location: Budapest, Hungary
- Job type: Permanent, full-time
- Hybrid working according to local policy
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Join our Global Clinical Sciences and Operation (CSO)s Clinical Quality Documentation team as a Quality Document Manager and you will be responsible for documenting clinical business processes, whilst ensuring coherence with related Quality Documents (QDs) and compliance with the Sanofi Quality system and documentation standards.
You will collaborate transversally with Subject Matter Experts (SMEs) across Clinical Operations departments and more widely with Pharmacovigilance, Regulatory and Medical and all Global R&D Business Units, as an active member of process improvement project teams. You will take the lead in writing and updating QDs (including process flowcharts) and coordinating their review and finalization in the Content Management System (CMS), also support audit and inspection preparation activities, and subsequently work with Quality Auditors to implement improvements and corrections to QDs as necessary.
Main responsibilities:
- With a focus on QD deliverables - contribute to scoping/planning process improvement projects; and organize/lead project meetings, documenting outcomes/actions
- Collaborate and negotiate with Process Optimization Manager and SMEs, to define, update and optimize clinical business processes
- Write QDs (Standard Operating Procedures, Working Instructions, and associated forms), using corporate templates and writing rules; design and program process flowcharts in our internal tool
- Coordinate QD review and manage SME comments
- Perform peer quality control (QC) of QDs; manage approval workflows for QDs in Content Management System (CMS) on the Veeva Vault platform; publish QDs
- Support the review and implementation of non-clinical QDs that are applicable to Clinical Operations staff
- Support inspection and audit preparation by identifying relevant QDs; and subsequently participate in discussions led by Quality Auditors to determine appropriate corrective and preventative actions
About you
Experience:
- Proven experience in Clinical Development/Operation (i.e., study management, medical writing, site monitoring, data management, statistics), and in-depth knowledge of international regulatory requirements on the conduct of clinical studies (ICH GCP guidelines)
- Knowledge of Quality Document Management Systems and Quality standards; and (preferably) process design tools
Soft Skills:
- Quality-focused and detail-oriented able to control the accuracy, reliability, and quality of technical/scientific documents
- Results-driven - able to multitask, prioritize assignments and manage a wide range of operational and strategic activities in parallel
- Able to analyze information, assess downstream impacts, and use deductive reasoning to solve issues and find innovative solutions
- Leader and facilitator able to deploy strong interpersonal and communication skills, to effectively lead global, multi-disciplinary teams
Technical skills:
- MS Office Suite
- Technical/scientific writing skills
Education:
- Bachelors (University) degree required, preferably in a scientific or medical discipline
Language(s):
- Fluency in spoken and written English, for daily use in a global environment
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
- Work from an "Office of the Year 2023" award winner with flexible home office policy
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
- Take 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 gen