Kite Pharma R&D Quality Internship: Poster Presented at PDA Week 2025

Area of Science:

• Pharmaceutical Quality Assurance
• Clinical Research and Development
• Regulatory Compliance

Background:

• Ensuring compliance with health authority regulations is critical in pharmaceutical R&D.
• A quality-driven culture is essential for reliable and safe drug development.
• Effective training in Good Clinical Practices (GCP) is vital for all personnel.

Purpose of the Study:

• To gain practical experience in R&D Quality at Kite Pharma.
• To contribute to the enhancement of regulatory compliance and quality culture.
• To develop and implement training materials for improved GCP understanding.

Main Methods:

• Prepared for regulatory inspections through timeline reconciliation and gap analyses.
• Developed mock inspection documentation and updated Standard Operating Procedures (SOPs).
• Created engaging training materials, including a GCP training game, and conducted a training gap analysis.

Main Results:

• Successfully supported preparations for regulatory inspections.
• Enhanced consistency through SOP updates and improved GCP understanding via training initiatives.
• Identified training gaps in GCP audit report writing to inform future development.

Conclusions:

• The internship reinforced the critical role of quality in patient safety, product reliability, and risk management.
• Strengthened understanding of the importance of robust quality systems in innovative therapy development.
• Further solidified interest in pursuing a career in pharmaceutical Quality Assurance.