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Director, Quality Assurance

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Director of Quality Assurance

Northeast

Our client is a biotechnology leader in gene therapy research on the East coast with a focus on novel gene/cell therapy products addressing blood-brain barrier technology. This position will offer exposure to cutting-edge gene therapy in a Discovery and Translational research environment, in collaboration with big pharma sponsor companies.

This position will offer exposure to cutting-edge gene therapy in a Discovery and Translational research environment, with heavy interactions within-vivo genome editing. You will work on successful treatments that cure the deadliest diseases in the world.

Responsibilities:

  • Prepare and serve as program liaison for inspections and audits, and address audit reports following the inspections
  • Conduct training sessions and assist in training personnel and documenting training sessions
  • Manage and supervise QA unit, coordinate implementation, and management of the QA unit across all facilities
  • Manage staff to conduct internal audits, validations/qualification plans and reports, and document control and records, training, and proficiency testing
  • Perform qualification audits of subcontractors, external audits for Good Laboratory Practice materials, processes, and studies from outside sites

 

Qualifications:

  • Master’s degree in life sciences and 7-10 years of experience in quality assurance
  • Effective team management skills, workflow management & performance management skills
  • Experience working in GLP/GMP environment and knowledge of GLP/GMP’s required
  • Experience in cell and gene therapy
  • Experience with Microsoft Word, Excel, and Access databases