California Licensed Senior Consultant

Job Summary

A company is looking for a Senior Consultant, CMC / GMP Documentation & Quality Control.

Key Responsibilities

• Perform detailed quality review of CMC documentation including specifications and batch records
• Review GMP documentation for compliance with global regulatory requirements and recommend corrective actions
• Support inspection readiness by ensuring documentation is accurate and complete

Required Qualifications

• Extensive experience in CMC and GMP documentation review
• Knowledge of FDA, EMA, ICH, and global regulatory requirements
• Experience with quality control documentation and analytical methods
• Ability to collaborate with cross-functional teams and external partners
• Experience in supporting regulatory inspections and responses