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Job Title: Clinical Project Quality Manager Location: Morristown, NJ About the Job 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 About Sanofi: 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 approachesQuality Control : Represents Quality on project/study team meetings, providing quality and continuous improvement supportProactively monitors progress status of assigned projectsProvides advice on GCP and Quality issuesMaster thoughtful risktaking methods to identifies and analyzes risks and opportunities with potential impact on study qualityLeverage extensive set of quality metrics to secure controlInspection Readiness: Implements in-process quality checks and utilizes performance metrics to inform decisions and prioritize actions to secure inspection readiness throughout study durationDrives Pre-Approval Inspection preparation activitiesQuality Issues & Risk Management Assesses and confirms escalated critical deviations, evaluates needs for regulatory reportingApplies data analytics to identify quality trends and patterns and recommends corrective and preventive actions based on quality data analysisAnalyzes signals/events to profile quality risks and propose mitigation strategiesManages quality alerts for assigned studies/projectsHandles cases of Scientific Misconduct and Serious GCP Non-Compliance at study level or program levelGCP Audit Contributes to the development of clinical audits plan for assigned programs through the identification of risks to Auditing teamAnalyses of audit results, monitors audit findings and ensures effectiveness of CAPAs implementedFoster a Quality Culture Conducts project/study level trend analysis of deviations or audit findingsImplement data driven approach to enable study team to focus on issues that matter to qualityContributes to continuous quality improvement initiativesPromotes a culture of early issue detection & timely resolutionProvides mentoring and training to newcomersAbout You Skills that you have (mandatory): Education: Bachelor degree in life/medical/natural sciences or scientific disciplineExperience: 5+ years experience in the pharmaceutical industry, with experience in GCP clinical and/or GCP quality operations-related rolesExperience with quality management systems and toolsLanguages: Competent in English (both written and verbal)Technical Skills: Working knowledge of international regulations/Guidelines/Good Practices in the clinical domainBasic proficiency in data analytics tools (e.g., Excel, Power BI)Ability to interpret quality data and metricsGood working knowledge of standard computer office softwareUnderstanding of digital quality management systemsSoft Skills: Quality focused with a high degree of personal accountabilityAnalytical thinking and problem-solving abilitiesAbility to analyze situations and provide guidance using a risk-based approachProject management skills and ability to influence without direct authorityExcellent communication and interpersonal skillsAbility to multi-task and prioritize assignmentsSelf-motivated with ability to work independentlySkills that you could improve in this new position (to develop): Experience: Exposure to sponsor and study sites GCP inspections by regulatory agenciesWorking in an international environmentDigital & Analytics Skills: Understanding of AI applications in clinical quality managementProficiency in quality data visualization and reporting toolsAbility to use digital platforms for quality risk assessmentUnderstanding of data integrity principles in digital environmentsSoft Skills: Personal leadership to interface with all levels of the organizationFacilitation skills for leading cross-functional meetingsTechnical Skills: Analytical abilities to interpret trends and support action plansStrategic thinking to conduct impact assessments and root cause analysisKnowledge of drug development process and worldwide GCP compliance regulationsUnderstanding of digital transformation in clinical operationsSkills that you could offer in addition (nice to have): Experience managing cross-functional Quality projectsExperience with regulatory submissions and GCP inspectionsKnowledge of risk management techniquesAdditional languages: French, ChineseWhy 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, whether it's through a promotion or lateral move, at home or internationally.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' gender-neutral parental leave.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. #GD-SA #LI-SA #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.