Sr Manager, Quality Assurance

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

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.

Responsibilities:

• Provide support on behalf of product quality leader to Kite’s fast-moving clinical programs through overseeing and managing the quality assurance and quality control processes for viral vector and T cell

• Manage the process material specifications for viral vector and T cell including the development and approval of justification of specifications.

• Develop process material quality control strategy

• Leads change management activities stemming from Kite driven changes to the control strategy that may impact Process Material Specifications (PMS) and/or Justification of Specification (JOS)  and/or JOS.  Assesses impact of CMO/CDMO initiated changes with potential to impact the control strategy, PMS or JOS documents

• Strong scientific leadership related to global regulatory filing strategies, analytical comparability and specifications. 

• Review internal technical documents for compliance with international regulatory and internal Kite standards (including but not limited to procedures, analytical test method procedures, qualification protocols/reports, etc.)

• Authors quality technical internal documents relating to product quality (including but not limited to, protocols to generate data, internal specification/justification of specifications, and technical reports/memos that connect CMC strategy to site operational details)

• Own and approve quality records including change controls, CAPAs, and deviations, as appropriate. Complete product quality impact assessments regarding proposed product changes.

• Complete data verification of source documents submitted to health authorities

• Attend the CMC team meetings, as appropriate, and support the goals and deliverables of the CMC team

• Attend and lead product quality team (or relevant sub-team) meetings

• Exhibit the capacity to communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences.

• Demonstrate the ability to influence others through persuasive interactions and garner support for novel solutions where applicable.

• Show the capacity to operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes. 

• Provide project management support to ensure timely completion of project deliverables

• Additional duties as assigned.

Basic Qualifications:

• 8+ Years with BS/BA
  OR

• 6+ Years with MS/MA or MBA

Preferred Qualifications:

• Master’s Degree and 5+ years’ experience with increasing responsibility in a quality, analytical development, process development, regulatory, or manufacturing environment OR

• Bachelor’s Degree and 7+ years’ experience with increasing responsibility in a quality, analytical development, process development, regulatory, or manufacturing environment OR

• High School Degree and 11+ years’ experience with increasing responsibility in a quality, analytical development, process development, regulatory, or manufacturing environment

• Experience in viral vector and T-cell quality control, including method development/qualification/validation and tech transfers, OOS/OOT investigations and trending

• Understanding of cell therapy and drug product development and manufacturing.

• In-depth knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals is preferred.

• Experience in Project Management in support of biopharmaceutical development.

• There is a strong preference for candidates who are familiar with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions.

• Prior experience in direct interaction with regulatory agencies during inspections or meetings is helpful.

• Knowledge of analytical techniques used for biologics product quality control with a preference for experience in analytical comparability assessments to support manufacturing changes.

• Previous experience working on a cross-functional team in a matrix environment is a plus.

• Excellent written and verbal communication skills, including facilitation and presentation skills are important. 
   

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

 

The salary range for this position is: $143,225.00 - $185,350.00. 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.