Csu Regional Quality Lead, Process

6 days ago

Budapest, Hungary Sanofi-Aventis Deutschland GmbH Full time

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 Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider.


Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen.


Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.

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