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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 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 risktaking methods to identifies and analyzes 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 audits plan for assigned programs through the identification of risks to Auditing team

+ Analyses of 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.

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Pursue** **_progress_** **, discover** **_extraordinary_

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

_US and Puerto Rico Residents Only_

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

_North America Applicants Only_

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 (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .

Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)