QA Team Lead

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 We are seeking a highly motivated individual to join us as a Quality Assurance Team Lead. In this role you will support the activities of the Quality Assurance department at Kite’s Frederick, MD manufacturing site. The Quality Assurance Team Lead will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality objectives. ***Shift is Sun-Wed 5:00 pm- 3:30 am*** Responsibilities (included but not limited to): Works with the Manufacturing, Quality Control, Materials Management, and Facilities/Engineering departments as a Quality Assurance representative. Provides oversight of the shift of QA specialists responsible for supporting operations at the site. Performs apheresis accession of patient material and elevate any nonconformances to the appropriate global teams. Performs shipment authorization of final product. Performs the inspection of final product labels to be released for GMP use. Coordinate and facilitate Quality Assurance (QA) production related activities, including: Review of electronic batch records and manufacturing labels. On-the-floor quality support to manufacturing and QC staff including real-time review of process comments. Assessment and closure of laboratory investigations. Timely assessment and closure of batch and material hold events. Review of batch manufacturing and testing documentation for timely delivery of final product. Ensures that tests are performed and products are manufactured in compliance with Kite specifications and regulatory and GMP guidelines. Supports development of SOPs and reviews/approves SOPs to ensure quality objectives are met. Reviews and approves test methods, manufacturing/quality control qualification/validation protocols, and reports. Provides QA support resolving material, in-process product, final product, environmental, facility, and equipment manufacturing issues. Provides QA oversight for site and network projects. Provides periodic updates to management for deviations, GMP and system issues, non-conforming materials and products and CAPA. Additional duties as assigned. These duties can be delegated to designated deputies of a satisfactory qualification level as needed. Basic Qualifications: MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 3+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR OR BA/BS in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR Associates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 7+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR High School diploma and 9+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product). Preferred Qualifications: Thorough knowledge of GMP, SOPs and Quality Systems Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards Ability to effectively negotiate and build collaboration amongst individuals Strong teamwork and collaborative skills Experience with manufacturing investigations, deviations, and CAPA. General knowledge of aseptic manufacturing processes. Proficient in MS Word, Excel, Power Point and other applications. Strong interpersonal, verbal and written communication skills Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities Willingness to think outside of the box and adapt best practices to a small, but growing environment Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies Self-motivated,detail-oriented,andwillingtoaccepttemporaryresponsibilitiesoutsideofinitialjob description. People Leader Accountabilities: Create Inclusion by demonstrating the business value of diverse and inclusive teams and embedding equity and respect into day to day people management practices. Develop Talent by understanding team members skills experience aspirations and potential and providing coaching feedback and development opportunities. Empower Teams by connecting team goals to organizational purpose removing barriers to execution and enabling cross functional collaboration. The salary range for this position is: $107,185.00 - $138,710.00. 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: * 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 Sign up to follow @KitePharma on Twitter at 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 View email address on click.appcast.io 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: #J-18808-Ljbffr Kite Pharma