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Graduate Intern, R&D Quality and Medical Governance

United States - California - Santa MonicaClinical Development & Clinical OperationsIntern
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Job Description

We are seeking highly motivated and passionate individuals to join our Summer Internship Program! As an intern at Kite, you’ll have the unique opportunity to learn about cell therapy from some of the brightest minds in biotech while making a meaningful impact. We’re committed to developing early talent, and we welcome motivated individuals with a passion for transforming the way cancer is treated. The program also offers the opportunity for networking within Kite and Gilead, social events with fellow interns and Kite leadership as well as career development trainings while providing competitive compensation and relocation assistance for eligible candidates.

The Role:

This role is based out of our Santa Monica office, where you will be learning about our Research and Development, Quality and Medical Governance (RDQMG) team. You will have the opportunity to learn about Kite RDQMG responsibilities and how we work cross-functionally within R&D and across both Kite and Gilead. We’ll teach you the focus of an R&D department, introduce the various functional areas within Kite R&D, and how we work to ensure quality and compliance oversight of our clinical studies to protect our patients. Finally, you’ll learn what it takes to run a successful Quality Management System (QMS).

The individual in this intern position will be responsible for aiding the Kite RDQMG team across our QMS: as we generate concise metrics for our organization, monitor training compliance, develop and manage deviations/CAPAs/Effectiveness Checks, partner with our study teams and various functional areas to provide compliance support and guidance, manage and conduct audits, develop and manage procedure documents, partner with our vendors to maintain oversight and compliance, and globally expand our trials to reach more patients.

Responsibilities:

  • Researching 21 CFR and/or ICH E6 R2/R3 and other relevant regulations

  • Analyzing data for compliance

  • Assisting in deviation, CAPA plan, and effectiveness check management and execution

  • Assisting in Regulatory Authority inspection readiness and preparation activities

  • Assisting in managing GxP and REMS audits

  • Assisting in generating metrics from our Quality Management System (QMS)

  • Distributing meeting agendas and writing meeting minutes

Basic Qualifications:

  • 18 years or older

  • Minimum GPA of 2.8

  • Eligible to work in the United States without work authorization sponsorship now or in the future

  • Currently enrolled in a full-time graduate degree program at an accredited U.S. based university/college

  • Completed at least one year of study at an accredited university/college prior to internship commencing

  • Enrolled full-time in the Fall Semester at an accredited U.S. based university/college after the completion of the internship – with earliest graduation date of December 2024 or Spring/Summer 2025

  • Able to complete a 10-12 consecutive week internship between May and August

  • Able to relocate if necessary and work at the designated site for the duration of the internship

  • Not be employed at the time the internship starts

Preferred Qualifications:

  • Currently enrolled in Graduate Degree with emphasis in Regulatory Science, Pharmacy, Law, or other science related degree

  • Proficiency with MS Office Suite

  • Ability to identify issues and seek solutions

  • Ability to work both independently and collaboratively in cross functional teams in fast paced, dynamic team setting

  • Efficient, organized, and able to handle short timelines in a fast-paced environment

  • Experience and/or interest in the Biotechnology, Pharmaceutical or health-care industry

  • Knowledge and understanding of Good Clinical Practices (GCP)

  • Creative and thoughtful problem-solving skills

  • Interest in clinical trial compliance

  • Interest in learning about audits and regulatory authority inspections (e.g. FDA, EMA, etc.)

  • Interest in learning about a Quality Management System (QMS)