Quality Assurance Systems Associate

Gamida Cell is an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. Gamida Cell is a publicly traded company (Nasdaq: GMDA).

Omidubicel, Gamida Cell’s lead investigational product candidate, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

Job Description

  • Assist with implementation and continuous improvement of quality systems (incl. training, change control, deviation, CAPA)
  • Initiate, revise, review and approve cGMP policies and procedures related to quality systems and training
  • Collaborate with functional departments for investigations, risk assessments, change controls, deviations, and CAPA
  • Conduct routine internal audits of the functional departments to ensure compliance with industry and regulatory expectations
  • Participate in external audits with management oversight
  • Prepare and distribute internal audit reports and findings, track and trend audit results
  • Support implementation of training programs for systems and policies
  • Facilitate online and classroom training

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree or higher in science/related field or equivalent work experience
  • Experience in a GMP quality, Engineering, or Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization (Minimum of 1 year)

To apply: Send resume and cover letter to zivw@gamida-cell.com.

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