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Clinical Project Quality Manager

Clinical Project Quality Manager

SanofiMorristown, New Jersey, US
30+ days ago
Job type
  • Full-time
Job description

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.

    #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.

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    Project Manager Quality • Morristown, New Jersey, US

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