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
