Director, Field Quality Assurance

Director, Field Quality Assurance

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.

General Scope and Summary

The Director of Field QA will work cross functionally to lead the assessment and monitoring program for transplant centers (TC) that supports commercial sites and expansion to new commercial products. This role will be a hands-on resource reporting to Quality.

  • Company: Gamida Cell, Ltd.
  • Posting Title: Director, Field Quality Assurance
  • Function: Quality
  • Location: Remote

Roles and Responsibilities

  • Establish and execute and improve the TC assessment process that will use risk- based tools for assessment, training, monitoring, in addition to expansion of the program to new commercial products
  • Collaborate with Commercial, Medical Affairs, Regulatory, IT, Clinical Operations, Manufacturing, Operations and Supply Chain to execute and improve processes that include the interlinked process elements of patient identification, COI/COC and logistics
  • Perform selection assessment requirements
  • Develop and execute TC change management process, related to the hospital site changes, that includes equipment, process and product management
  • Manage the assessment and monitoring schedule of approved TC list
  • Quality contact for TC issues and discrepancies with GCA, Medical Affairs Call Center and Operations Quality
  • Support inspection readiness plans and interact with regulatory agencies during inspections on TC related matters
  • Lead and develop a team that executes and improves TC assessment program
  • Perform other duties as assigned

Experience, Education and Specialized Knowledge and Skills

  • Bachelor’s degree in biological sciences or related field; Master’s degree preferred
  • Minimum of 10 years progressive experience in pharmaceutical or biologics quality systems’ roles; biologics, blood/human tissue, cell therapy or vaccines experience preferred
  • Minimum of 3-5 years of management/leadership experience
  • Experience auditing and assessing TC preferred. External suppliers, and/or internal GMP systems audits
  • ASQ Certified Quality Auditor preferred
  • Strong working knowledge of and ability to apply GMP and FACT guidelines in conformance to US, EU and ROW standards
  • Experience presenting and responding to regulatory agency, internal and/or corporate audits
  • Proficient in MS Word, Excel, and Power Point
  • Demonstrated ability to develop, coach, and mentor employees
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment with external medical professionals and internal Commercial colleagues
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description

Travel: Ability to travel up to 60%
Reports to: QA Director, Quality Systems

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

 

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