Lead Quality Assurance Manager

4 days ago


Fremont, California, United States Alexza Full time
Quality Assurance Leadership Opportunity:

The Senior Director, Quality Assurance Operations leads the Quality Assurance operations and systems group at Alexza. This role is responsible for directing the execution of quality processes for both commercial and clinical products manufacturing, testing, and design development. The ideal candidate will have a strong understanding of cGMP regulations (US and EU) and experience in managing cross-functional teams.

Main Responsibilities:
  • Directing the Quality Assurance operations and systems group to execute on quality processes for both commercial and clinical products manufacturing, testing, and design development.
  • Liaising with stakeholders to identify and mitigate quality risks.
  • Maintaining detailed and accurate records.


Requirements:
  • Bachelor's degree in a scientific or related discipline.
  • A minimum of 10 years of experience in cGMP regulations (US and EU).
  • Excellent verbal and written communication skills.
  • Familiarity with electronic Quality Management Systems (eQMS).


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