Senior Director Quality Assurance Operations

7 days ago


Fremont, California, United States Alexza Full time
Job Summary:

The Senior Director, Quality Assurance Operations is responsible for directing the Quality Assurance operations and systems group to execute on quality processes for both commercial and clinical products manufacturing, testing, and design development.

Main Responsibilities:
  • Directs the Quality Assurance operations and systems group to execute on quality processes for both commercial and clinical products manufacturing, testing, and design development.
  • Leads cross-functional teams in data collection and evaluation of commercial products and delivers product quality review reports annually.
  • Liaises with stakeholders to identify and mitigate quality risks.


Requirements:
  • Bachelor's degree in a scientific or related discipline.
  • A minimum of 10 years of experience in cGMP regulations (US and EU).
  • Strong leadership ability, both within the department and in cross-functional team settings.
  • Ability to maintain detailed and accurate records.
  • Familiarity with electronic Quality Management Systems (eQMS).


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