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Senior Quality Project Manager CAR-T

Janssen Pharmaceuticals, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Project Manager, CAR-T preferrablly located in Raritan, NJ; Malvern, PA; Beerse Beligum or Leiden, Netherlands. Other J&J global location may be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

The Senior Quality Project Manager, CAR-T is responsible for leading and providing quality oversight over a wide range of projects and activities within and beyond the cell therapy manufacturing facilities and testing sites to support both clinical and commercial requirements.

  • Lead quality driven continuous improvement projects, COGs reduction efforts, and network initiatives. Develop robust model to track and report out on quality project progress.
  • Act as liaison for the quality team in support of global CAR-T projects and strategies.
  • Lead the establishment of a framework for E2E analytical oversight for CAR-T therapies. Develop global testing strategies and related analytical capacity across the network for CAR-T therapies.
  • Partner with program teams to evaluate Q&C and analytical CAR-T projects and opportunities and determine priority actions that align with the platform strategy.
  • Lead knowledge transfer program from US to EU CAR-T facility, and beyond.
  • Lead method transfer activities from US to EU facilities according to project delivery timelines as well as any updated/improved methods from AD.
  • Identify and lead global QA and QC strategic optimization projects for both EU/US CAR-T facilities (e.g. automation, robotisation of QA or lab activities), including capacity and expansion projects.
  • Manage cross-functional projects with many stakeholders. Collaborate with functional departments to resolve issues. Collaborate with Functional Leads/Subject Matter Experts in driving execution.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Require minimal direction to complete tasks, know how to get resources and information from established internal contacts; consult with supervisor for decisions outside of established processes.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Qualifications

    Experience and Skills:

    Required:

  • A minimum of a Bachelor’s Degree is required. Degree concentration in Life Science or technical discipline is preferred
  • A minimum of eight (8) years of experience in the pharmaceutical industry
  • Experience in Quality Assurance/ Quality Control / Quality Systems / Compliance
  • Project Management experience
  • Experience working with Quality Systems
  • Knowledge of cGMP regulations and FDA/EU guidance
  • Good written and verbal communication skills
  • This position may require up to 15% of domestic and international travel.
  • Preferred:

  • Knowledge of Good Tissue Practice and experience with cell-based manufacturing/testing
  • Experience working in an aseptic manufacturing facility
  • Lean Six Sigma or other Process Excellence and/or PMP certification
  • Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

    Senior Quality Project Manager CAR-T

    Johnson & Johnson, Beerse
    Categories: 
    Project Manager
    Degree level: 
    Bachelor
    Career level: 
    Senior