Sanofi
Base pay range
$108,750.00/yr - $157,083.33/yr 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 approaches Quality Control:
Represents Quality on project/study team meetings, providing quality and continuous improvement support; proactively monitors progress status of assigned projects; provides advice on GCP and Quality issues; applies thoughtful risk-taking methods to identify and analyze risks and opportunities with potential impact on study quality; leverages a set of quality metrics to secure control Inspection Readiness:
Implements in-process quality checks and utilizes performance metrics to inform decisions and prioritize actions to secure inspection readiness throughout study duration; drives Pre-Approval Inspection preparation activities Quality Issues & Risk Management:
Assesses and confirms escalated critical deviations, evaluates needs for regulatory reporting; applies data analytics to identify quality trends and recommends corrective and preventive actions; analyzes signals/events to profile quality risks and propose mitigation strategies; manages quality alerts for assigned studies/projects; handles cases of Scientific Misconduct and Serious GCP Non-Compliance at study or program level GCP Audit:
Contributes to the development of clinical audits plan for assigned programs through the identification of risks to Auditing team; analyzes audit results, monitors findings and ensures effectiveness of CAPAs Foster a Quality Culture:
Conducts project/study level trend analysis of deviations or audit findings; implements data driven approaches to focus on issues that matter to quality; contributes to continuous quality improvement initiatives; promotes a culture of early issue detection & timely resolution; provides mentoring and training to newcomers About You
Skills that you have (mandatory)
Education:
Bachelor degree in life/medical/natural sciences or scientific discipline Experience:
5+ years in the pharmaceutical industry, with experience in GCP clinical and/or GCP quality operations-related roles; experience with quality management systems and tools Languages:
Competent in English (written and verbal) Technical Skills:
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 office software; understanding of digital quality management systems Soft Skills:
Quality focused with strong accountability; analytical thinking and problem-solving; risk-based decision making; project management and influencing without authority; excellent communication and interpersonal skills; ability to multi-task and prioritize; 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; data visualization and reporting tools; digital platforms for quality risk assessment; 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 for impact assessments and root cause analysis; knowledge of drug development and worldwide GCP compliance Understanding of digital transformation in clinical operations Nice-to-have skills
Experience managing cross-functional Quality projects; regulatory submissions and GCP inspections; knowledge of risk management techniques; additional languages such as French or Chinese Why Choose Us?
Grow your talent and drive your career with opportunities for promotion or lateral moves, at home or internationally Rewards package that recognizes your contribution and amplifies your impact Health and wellbeing benefits including comprehensive healthcare and 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 status, sex, gender identity or expression, disability, veteran or military status, or any other characteristic protected by law. Job metadata
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing Note: This refined description consolidates and reformats the original content to meet readability and structural standards. It retains the substantive job information while removing extraneous boilerplate and site-specific notices.
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$108,750.00/yr - $157,083.33/yr 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 approaches Quality Control:
Represents Quality on project/study team meetings, providing quality and continuous improvement support; proactively monitors progress status of assigned projects; provides advice on GCP and Quality issues; applies thoughtful risk-taking methods to identify and analyze risks and opportunities with potential impact on study quality; leverages a set of quality metrics to secure control Inspection Readiness:
Implements in-process quality checks and utilizes performance metrics to inform decisions and prioritize actions to secure inspection readiness throughout study duration; drives Pre-Approval Inspection preparation activities Quality Issues & Risk Management:
Assesses and confirms escalated critical deviations, evaluates needs for regulatory reporting; applies data analytics to identify quality trends and recommends corrective and preventive actions; analyzes signals/events to profile quality risks and propose mitigation strategies; manages quality alerts for assigned studies/projects; handles cases of Scientific Misconduct and Serious GCP Non-Compliance at study or program level GCP Audit:
Contributes to the development of clinical audits plan for assigned programs through the identification of risks to Auditing team; analyzes audit results, monitors findings and ensures effectiveness of CAPAs Foster a Quality Culture:
Conducts project/study level trend analysis of deviations or audit findings; implements data driven approaches to focus on issues that matter to quality; contributes to continuous quality improvement initiatives; promotes a culture of early issue detection & timely resolution; provides mentoring and training to newcomers About You
Skills that you have (mandatory)
Education:
Bachelor degree in life/medical/natural sciences or scientific discipline Experience:
5+ years in the pharmaceutical industry, with experience in GCP clinical and/or GCP quality operations-related roles; experience with quality management systems and tools Languages:
Competent in English (written and verbal) Technical Skills:
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 office software; understanding of digital quality management systems Soft Skills:
Quality focused with strong accountability; analytical thinking and problem-solving; risk-based decision making; project management and influencing without authority; excellent communication and interpersonal skills; ability to multi-task and prioritize; 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; data visualization and reporting tools; digital platforms for quality risk assessment; 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 for impact assessments and root cause analysis; knowledge of drug development and worldwide GCP compliance Understanding of digital transformation in clinical operations Nice-to-have skills
Experience managing cross-functional Quality projects; regulatory submissions and GCP inspections; knowledge of risk management techniques; additional languages such as French or Chinese Why Choose Us?
Grow your talent and drive your career with opportunities for promotion or lateral moves, at home or internationally Rewards package that recognizes your contribution and amplifies your impact Health and wellbeing benefits including comprehensive healthcare and 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 status, sex, gender identity or expression, disability, veteran or military status, or any other characteristic protected by law. Job metadata
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing Note: This refined description consolidates and reformats the original content to meet readability and structural standards. It retains the substantive job information while removing extraneous boilerplate and site-specific notices.
#J-18808-Ljbffr