R&D Quality Specialist -Biopharma

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

RESPONSIBILITIES:

• You will act as R&D Quality primary point-of-contact for assigned R&D groups for quality events and CAPA management. You may have responsibilities for advising R&D groups on quality events, inspection and CAPA management and administration practices and standards, including advising on appropriate CAPA activities to address quality events and deviations.  You may also lead special projects, such as new practices, processes or tools that enable continuous evolution and streamlining for R&D inspections and CAPA management. You will support regulatory inspection activities, provide quality event and CAPA management training and in training new team members on departmental policies, practices and procedures. Work includes:

• Gilead policies, practices, procedures, and regulatory requirements
• Gilead systems (electronic Quality Management System) and other tools for managing quality events, deviations, and CAPAs
• Activities required to address quality incidents or deviations, including specific advice on appropriate corrective and preventative actions (CAPAs)
• Regulatory and Gilead requirements for regulatory inspections and responses to regulatory agency inquiries

• Will support internal R&D for assigned R&D groups or locations.

• Conducts inspection and CAPA management activities, such as managing quality events in the electronic Quality Management System CAPA report issuance, audit and CAPA management follow-up and associated communications, and audit and CAPA closure.

• May provide R&D Quality support for inspections and CAPA management administrative and systems support, such as:

• Managing, tracking and reporting on R&D quality inspections, quality events such as deviations, and CAPA management
• Providing systems and reporting training to others
• Performing quality checks on data and reporting to ensure accuracy, completeness and complianceSupporting administrative coordination, scheduling and reporting related to R&D Quality inspections

• Participates in continuous improvements to R&D quality audits, inspections and CAPA management processes, policies, procedures, practices and tools.

• Will support GxP training for other colleagues and train new team members on departmental policies, practices and procedures.

• Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.

• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

 

BASIC REQUIREMENTS:

• MA/MS/MBA with 2+ years’ relevant experience.

• BA/BS with 4+ years’ relevant experience.

PREFERRED REQUIREMENTS:

• Experience working with quality-controlled document management systems is strongly preferred.

• Experience writing or updating business processes is preferred.

• Quality and compliance experience working with medicinal products in the biopharma industry is preferred.

• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

• Demonstrates advanced knowledge of quality and compliance requirements for medicinal products, including varying regional requirements.

• Demonstrates strong attention-to-detail and good organizational skills.

• Demonstrates strong proficiencies in the Microsoft Office suite.

• Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.

• Ability to communicate in a clear and concise manner.

• Ability to support a team-oriented, highly-matrixed environment.

• Ability to execute multiple tasks as assigned.

 

The salary range for this position is: $92,820.00 - $120,120.00. 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.
 

For 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 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.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.