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Quality Assurance Operations Manager

2 months ago

Seattle, Washington, United States EPM Scientific Full time

Quality Control Manager

Location: Hybrid

EPM Scientific is seeking a dedicated professional to oversee quality control within a prominent cell therapy organization specializing in T-cell therapies aimed at treating autoimmune and degenerative conditions. This position is pivotal in ensuring compliance and quality standards are met while working closely with various teams.

Key Responsibilities:

  • Oversee in-process, release, and stability quality control data for both raw materials and final products.
  • Develop and manage timelines, review content proactively, and provide expertise in quality and compliance.
  • Facilitate method transfer, validation processes, and ensure the integrity of analytical data.
  • Lead the management of timelines related to deviations, investigations, 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 focus on cell therapy.
  • Demonstrated management experience within quality control.
  • In-depth knowledge of CAPAs, deviations, change controls, investigations, out-of-specification (OOS), and out-of-trend (OOT) processes.
  • Familiarity with microbiology, qPCR, flow cytometry, ELISA, and cell-based assays.