Intern Quality Quality Management Systems

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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 youll have the unique opportunity to learn about cell therapy from some of the brightest minds in biotech while making a meaningful impact. Were 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. Well 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 youll learn what it takes to run a successful Quality Management System (QMS).

The individual in this intern position willbe 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.

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 enrolledin 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)

The expected hourly range for this position is $19.00 - $55.00.

Gilead considers a variety of factors when determining base compensation including education level and geographic location. These considerations mean actual compensation will vary.

Benefits include paid company holidays sick time and housing stipends for eligible employees.

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

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Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.