GLP Compliance Manager

Job Summary

Reporting to the Senior Director of GCP Compliance, the full-time Manager, GLP Compliance will manage compliance with Good Laboratory Practice (GLP) requirements across laboratory operations, develop quality control processes, and ensure regulatory adherence while collaborating with cross-functional teams.

Key responsibilities

• Ensure compliance with GLP regulations and company procedures across laboratory activities
• Develop and maintain quality control processes, performing routine assessments to identify compliance gaps
• Assist in planning and conducting internal audits and support regulatory inspections

Required qualifications

• Bachelor's degree in Biology, Chemistry, Clinical Laboratory Science, Life Sciences, or a related field
• Minimum of two years of experience in biopharmaceutical or laboratory operations in a GxP environment
• At least one year of experience in Document Control within a GxP setting
• Working knowledge of GLP, GCP, ICH guidelines, and FDA regulations
• Familiarity with Quality Management Systems (QMS) and electronic document management systems