GCP Quality Consultant

Job Summary

A company is looking for a GCP Quality Consultant to support clinical stage biotech operations.

Key Responsibilities

• Conduct auditing of investigators, CROs, contract labs, and TMFs
• Maintain TMF and provide input on clinical trial protocols and study reports
• Update Quality Management Systems (QMS) and generate CAPAs

Required Qualifications

• Seasoned quality professional with hands-on experience
• GMP focus with an understanding of GLP-GMP
• Experience in Allergy/Immunology is preferred but not essential
• Ability to operate independently and manage clinical quality activities
• Experience with intravenous and subcutaneous injectable dosage forms