**CSU Regional Quality Lead, Process & Training** + _Location:_ _Hungary, Budapest or Belgium, Diegem or Czech Republic, Praha or Denmark, Berlin, or Italy, Milano or Poland, Warsaw_ + _Hybrid working pattern_ **About the job** This position is open to all countries with a CSU Footprint in EU. The CSU Regional Quality Lead Process and Training (RQLPT) is a Clinical Study Unit (CSU) region-based role which is part of a broader network of quality professionals who ensure alignment and compliance to the Sanofi R&D quality system and related clinical operations activities within the Sanofi Group and are linked to Clinical Sciences & Operations (CSO) Platform. This role also works in collaboration with the respective Country Quality Head (CQH) at country level(s) to ensure local clinical studies related activities are managed as per the expectations within the Global Quality System and R&D Platform and other local GXP related activities. As such, the Regional Quality Lead Process and Training acts as an extension of the Clinical Quality & Continuous Improvement department (CQ&CI) at regional level (CSU and satellite related countries) for the management of Quality Documents / Processes and for any action toward the continuous improvement and optimization of these. The Regional Quality Lead Process and Training is responsible to develop, monitor and adjust the End-to-End Quality Document (QD) strategy for the CSU worldwide together with the CSU Quality leads Process and Training from the other regions and the Head Global CSU Process and Training. They ensure the identification, development, support, implementation and improvement of clinical global and local CSU QDs. They assess and decide on the need for local CSU QDs and process manuals in collaboration with the Head global CSU Process and Training and the CQ&I representative for this topic. The Regional Quality Lead Process and Training develops, oversees, and ensures updates and governance, of the training program. They identify needs for training and prepare/update/review any of CSU-related training program topics [e.g. for new global and local tools, other local requirements and /or specificities). The Regional Quality Lead Process and Training is in charge of overseeing and promoting the maintenance of the appropriate qualification of the CSU staff and the documentation thereof for: + Corporate & CSU country/cluster (local) QDs and process manuals. + Good Clinical Practices (GCP). + International and local regulations. + Study management activities (e.g. mandatory role-based training). + Corrective & Preventive Actions (CAPA) in case of signal detection. + Collaboration with partner(s) to deliver CSU‐specific training. **About you** + In-depth knowledge of ICH-GCP, regulatory, and ethical frameworks for clinical studies. + **Level 3 Risk Management** : Anticipate, adapt, and execute plans to manage risks and foster innovation, while protecting company assets (Sanofi First). + **Level 2 Project Management** : Strong organizational skills for managing multiple projects and stakeholder engagement. + **Level 3 Data Analytics** : Analyze data trends, predict, forecast, and use benchmarks for strategic decision-making. + **Level 1 Medical/Scientific Knowledge** : Understanding of R&D therapeutic areas. + **Level 3 Clinical Development Knowledge** : Understands governance, product life cycle, and supports internal stakeholders (e.g., GBU, PV, Regulatory). + **Level 3 Problem-Solving** : Apply critical thinking, measure outcomes, and implement solutions. + **Level 2-3 Business Acumen** : Understands operations, departmental synergies, and aligns with strategic goals (internal and external). + **Level 3 Change Management** : Support change, overcome resistance, and act as a change agent. + **Level 3 Emotional Intelligence** : Integrate emotional awareness and social skills to manage relationships effectively. + **Level 3 Interpersonal & Relationship Management** : Influence and inspire others while respecting their opinions. + **Level 1 People Development** : Demonstrates essential people management qualities, such as setting SMART goals and performance discussions. + Trained in Compliance and Business Integrity. + Strong presentation, coaching, and mentoring skills. + Excellent communication and negotiation skills across global teams. + Proficient in IT tools (e.g., MS Office) for training materials and tracking. + Fluency in English (oral and written). **Why choose us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career. \#LI-EUR **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)