Intern - Quality - Quality Management Systems

Kite Pharma•Santa Monica, CA

44d•$19 - $55•Onsite

About The Position

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. 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 (RDQ) team. You will have the opportunity to learn about Kite RDQ 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 RDQ 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.

Requirements

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

Nice To Haves

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)

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