Clinical Project Quality Manager

Clinical Project Quality Manager

Join the engine of Sanofi's mission where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.

We lead clinical teams to implement quality focused best practices in daily study management so that it becomes a reflexive action. We support the team's ability to see how individual actions contribute to the collective goal of drug or vaccine registration to fulfil patient's needs, through successful pre-approval GCP inspection.

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main Responsibilities

Clinical Documents :

• Contributes to the development of key study documents (e.g. Protocol, Informed Consent Form, Study Risk Management Plan) to enable quality by design approaches.

Quality Control :

Inspection Readiness :

Quality Issues & Risk Management :

GCP Audit :

Foster a Quality Culture :

About You

Skills that you have (mandatory) :

Education : Bachelor degree in life / medical / natural sciences or scientific discipline.

Experience : 5+ years experience in the pharmaceutical industry, with experience in GCP clinical and / or GCP quality operations-related roles. Experience with quality management systems and tools. Competent in English (both written and verbal). Working knowledge of international regulations / Guidelines / Good Practices in the clinical domain. Basic proficiency in data analytics tools (e.g., Excel, Power BI). Ability to interpret quality data and metrics. Good working knowledge of standard computer office software. Understanding of digital quality management systems.

Technical Skills : Quality focused with a high degree of personal accountability. Analytical thinking and problem-solving abilities. Ability to analyze situations and provide guidance using a risk-based approach. Project management skills and ability to influence without direct authority. Excellent communication and interpersonal skills. Ability to multi-task and prioritize assignments. Self-motivated with ability to work independently.

Skills that you could improve in this new position (to develop) : Exposure to sponsor and study sites GCP inspections by regulatory agencies. Working in an international environment. Understanding of AI applications in clinical quality management. Proficiency in quality data visualization and reporting tools. Ability to use digital platforms for quality risk assessment. Understanding of data integrity principles in digital environments. Personal leadership to interface with all levels of the organization. Facilitation skills for leading cross-functional meetings. Analytical abilities to interpret trends and support action plans. Strategic thinking to conduct impact assessments and root cause analysis. Knowledge of drug development process and worldwide GCP compliance regulations. Understanding of digital transformation in clinical operations.

Skills that you could offer in addition (nice to have) : Experience managing cross-functional Quality projects. Experience with regulatory submissions and GCP inspections. Knowledge of risk management techniques. Additional languages : French, Chinese.

Why Choose Us?

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

The salary range for this position is : $108,750.00 - $157,083.33. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.