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.
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
This position will report to the Associate Director, Clinical Compliance. In this role you will be a key member of the Clinical Compliance team and work cross-functionally within the Kite Development Operations organization to proactively identify risk, mitigate noncompliance, and support inspection readiness activities.
Responsibilities:
The following activities will be conducted with manager guidance and oversight, as needed:
Collaborate with Development Operations through all stages of clinical trial conduct to ensure GCP compliance; this includes but is not limited to the implementation of procedures and study documents and support of sponsor oversight activities
Support the audit response process for Development Operations and follow CAPA commitments to completion
Support global inspection readiness activities
Support risk management activities
Support Development Operations in noncompliance reporting and CAPA development
Support and participate in internal audits and regulatory authority inspections as needed
Support internal compliance assessments, including reporting of results to functional area leadership, initiating deviations, and managing associated CAPAs
Analyze compliance data, create metrics, identify trends, and clearly communicate findings and recommended actions to management and stakeholders
Support efforts to increase compliance awareness and a culture of compliance; includes but is not limited to leading office hours, presenting lessons learned and important compliance updates
Support process and training compliance, including but not limited to bi-annual reconciliation of process communications
Maintain awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) to support Development Operations alignment
Lead by example to champion quality and compliance across the Development Operations organization
Basic Qualifications:
Master’s and 3 years of relevant experience
OR
Bachelor’s and 5 years of relevant experience
Preferred Qualifications:
Knowledge of international GCP regulatory requirements and applicable national regulations (e.g., FDA, MHRA, etc.)
Basic understanding of deviations, CAPAs, and risk management in clinical trials
Excellent communication skills, able to provide clear and concise instructions
Critical and creative thinking to be able to resolve complex problems
Ability to develop innovative solutions to maximize efficiency
Ability to prioritize and adjust workload with guidance
The salary range for this position is: $133,195.00 - $172,370.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma
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 disability, genetic 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 laws. In 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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.
Please apply via the Internal Career Opportunities portal in Workday.
At Kite, a Gilead Company, our singular focus is achieving cures with cell therapy. Our goal is to bring the promise of cell therapy to as many eligible patients as possible who may benefit.
Since 2009, Kite has been at the forefront of cancer immunotherapy. Today, we are proud to be the leader in engineered T cell therapy for hematologic malignancies, but we recognize that this is just the beginning. Patients are at the heart of our focus on the cure, which is why we are committed to pursuing cell therapy as a transformative treatment option for as many patients as possible who may benefit.
Unlike traditional pharmaceutical manufacturing, our therapies are not created on an assembly line. Cell therapy specialists at our manufacturing facilities reengineer a patient’s own immune cells to attack and fight their cancer cells — one patient at a time. That sense of connection to the people we serve motivates us daily at Kite.
Our corporate headquarters are located in Santa Monica, California, and we have dedicated cell therapy manufacturing facilities in California, Maryland and the Netherlands. If you’re passionate about bringing the curative potential of cell therapy to more eligible patients, let’s talk.
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