Sanofi (US)
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
Master thoughtful risk‑taking methods to identify and analyze risks and opportunities with potential impact on study quality
Leverage extensive 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 patterns and recommends corrective and preventive actions based on quality data analysis
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 level or program level
GCP Audit
Contributes to the development of clinical audit plan for assigned programs through the identification of risks to Auditing team
Analyses audit results, monitors audit findings and ensures effectiveness of CAPAs implemented
Foster a Quality Culture
Conducts project/study level trend analysis of deviations or audit findings
Implement data driven approach to enable study team 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 experience 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 (both 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 computer office software
Understanding of digital quality management systems
Soft 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) Experience
Exposure to sponsor and study sites GCP inspections by regulatory agencies
Working in an international environment
Digital & Analytics Skills
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
Soft Skills
Personal leadership to interface with all levels of the organization
Facilitation skills for leading cross‑functional meetings
Technical Skills
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?
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.
#J-18808-Ljbffr
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
Master thoughtful risk‑taking methods to identify and analyze risks and opportunities with potential impact on study quality
Leverage extensive 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 patterns and recommends corrective and preventive actions based on quality data analysis
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 level or program level
GCP Audit
Contributes to the development of clinical audit plan for assigned programs through the identification of risks to Auditing team
Analyses audit results, monitors audit findings and ensures effectiveness of CAPAs implemented
Foster a Quality Culture
Conducts project/study level trend analysis of deviations or audit findings
Implement data driven approach to enable study team 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 experience 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 (both 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 computer office software
Understanding of digital quality management systems
Soft 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) Experience
Exposure to sponsor and study sites GCP inspections by regulatory agencies
Working in an international environment
Digital & Analytics Skills
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
Soft Skills
Personal leadership to interface with all levels of the organization
Facilitation skills for leading cross‑functional meetings
Technical Skills
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?
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.
#J-18808-Ljbffr