Clinical Project Quality Manager

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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