Demo

Regulatory Compliance Specialist

Digital Prospectors
Brisbane, CA Full Time
POSTED ON 3/15/2025
AVAILABLE BEFORE 4/13/2025

Job Requirements

This Senior Manager position requires a strong background in quality assurance, analytical methods, and regulatory compliance in a CBER/CDER regulated environment.

The ideal candidate will have experience supporting analytical development and QC in biologics and small molecules, as well as a proven track record in QA.

Key Qualifications

  • Bachelor's degree or equivalent experience in Quality Control or a related field.
  • Minimum of 1 year of experience in QA and at least 5 years of experience within a regulated industry (CBER/CDER).
  • Experience managing relationships with contract testing labs and Contract Manufacturing Organizations (CMOs).

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