Senior Associate, Clinical Compliance

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

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 worlds 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 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:

• Masters and 3 years of relevant experience

OR

• Bachelors 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

For additional benefits information visit:

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 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:

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