Sr Manager GLP QA

1 month ago


Bellevue, United States Catalyst Life Sciences Full time

Catalyst is working with a growing Biotech to identify a Manager/Sr Manager GLP QA. This is a hybrid position (3 days on-site per week) that requires candidates to be based in San Francisco CA or Bellevue WA.


Responsibilities:

  • Lead the Preclinical Quality Assurance program to ensure development and implement strategies
  • Advise on GLP and other regulatory related matters
  • Collaborate cross functionally and manager supplier/vendor management
  • Report directly to the Head of QA and work on a global scale covering the preclinical QA program


Qualifications:

  • 10+ years of Quality Assurance experience with 5+ years of preclinical QA experience
  • Experience with GLP regulated studies that comply with FDA 21 CFR PT 58 (animal toxicology safety studies or global equivalent)
  • Experience auditing the nonclinical (GLP/GCLP) CROs and vendors


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