Qc Excellence Manager Car-t Emea

il y a 2 semaines

Beerse, Flandre, Belgique Johnson & Johnson Temps plein

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QC Excellence Manager for the CAR-T hub in Europe.

The position will be based in Beerse Belgium.
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.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy.

This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

The QC Excellence Manager, CAR-T will oversee and lead a wide range of projects within the QC department to support remediation and continuous improvement efforts, and all QC aspects of site projects, including the lab expansion.

In addition, they will lead the lab services functions, including the eLIMS, sample management, investigations, and equipment support teams.

Key Responsibilities

  • Provide QC input for site continuous improvement and remediation efforts. Schedule and manage QC tasks associated with these efforts.
  • Support and lead quality control continuous improvement projects.
  • Act as liaison for the quality control team in support of site improvement projects and strategies.
  • Collaborate with functional departments to resolve issues.
  • Manage crossfunctional projects with many stakeholders.
  • Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls.
  • Mentor, train and supervise quality control staff
  • Evaluate performance and provides opportunities for growth.
  • Require mínimal 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.
  • Other duties will be assigned, as necessary.

Qualifications:

  • A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
  • Experience leading, coaching, or supervising direct or indirect personnel or teams
  • Strong communication and interpersonal skills, a high level of organizational ability, attention to detail, and ability to work effectively in a collaborative environment globally (US and EU) is required.
  • Proficient knowledge of analytical technologies used in a Quality Control laboratory and method transfer
  • Experience working with Quality Systems
  • Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems is required
  • Good written and verbal communication skills
  • Knowledge of Good Tissue Practice and experience with cellbased manufacturing is preferred
  • Experience with LIMs and SAP or equivalent systems is preferred
  • Lean Six Sigma Certification is preferred

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