Quality Assurance Director

3 days ago


Pleasanton, Kansas, United States Crystal Pharmatech Full time
Job Overview

We are seeking a highly skilled Quality Assurance Director to join our team at Crystal Pharmatech.

The successful candidate will be responsible for ensuring compliance with Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) regulations in our nonclinical laboratory study.

Main Responsibilities:
  • Inspection Management: Host client and regulatory inspections, including preparing responses to findings.
  • Regulatory Support: Assist organization regulatory professionals across BABM sites.
  • Compliance Auditing: Ensure GLP protocol requirements are met by auditing phase-specific raw data, data summary tables, draft and final phase reports associated with nonclinical studies or bioanalytical sample analysis protocols.
Requirements:
  • Bachelor's degree in biological or physical sciences required; advanced degrees preferred.
  • 10+ years of relevant Regulatory Affairs experience in the Bioanalytical CRO space and/or biotechnology/pharmaceutical industry.
  • Able to provide regulatory leadership and guidance on cross-functional teams.
Estimated Salary: $120,000 - $180,000 per year

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