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Quality Assurance Lead

2 months ago

Seattle, Washington, United States EPM Scientific Full time

Position: Quality Control Manager

Location: Hybrid

EPM Scientific is seeking a skilled professional to oversee quality control processes within a dynamic cell therapy organization specializing in T-cell therapies aimed at treating autoimmune and degenerative conditions. This managerial role operates outside of laboratory settings and reports directly to the Quality Assurance department.

Key Responsibilities:

  • Oversee the management of in-process, release, and stability quality control data pertaining to both raw materials and final products.
  • Develop and maintain timelines, conduct proactive reviews of content, and offer expertise in quality and compliance matters.
  • Facilitate method transfers, method validations, and ensure the integrity of analytical data.
  • Manage timelines for deviations, investigations, corrective and preventive actions (CAPAs), and change controls.
  • Foster and maintain collaborative relationships with both internal and external stakeholders.

Qualifications:

  • Proven experience in the biotech or pharmaceutical sector, with a preference for expertise in cell therapy.
  • Demonstrated management experience within quality control functions.
  • In-depth knowledge of CAPAs, deviations, change controls, investigations, out-of-specification (OOS), and out-of-trend (OOT) scenarios.
  • Familiarity with microbiological techniques, quantitative PCR (qPCR), flow cytometry, enzyme-linked immunosorbent assays (ELISA), and cell-based assays.