**For Current Kite Pharma Employees and Contractors:** Please log onto your Internal Career Site at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld to apply for this job **Job Description** Kite is seeking a Senior Director, Quality Control who will be responsible for clinical site Quality Control, including analytical, microbial, stability and sample management groups and activities. You will also be tasked with staging appropriate validation of bioanalytical methods for cell therapy products and in-process/final product testing and stability testing methods. **Responsibilities include (but are not limited to):** + Manage analytical, microbial, stability and sample management groups to ensure timely testing. Manage method transfer and phase appropriate qualification/validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to a contract-testing lab. + Responsible for OOS, deviations. + Draft analytical and stability sections of BLA, IND. + Responsible for method transfer to commercial site, method comparability, training of analysts. + Monitor and trend data + Assemble reports on product release test monitoring of Kite's cGMP facility. Frequently update management on trends. Implement corrective action plans when necessary + CMO and OTL tracking to complete lot disposition + Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Generation of CoAs for product release + Responsible for stability program of clinical stage products. + Support in-process and final specification system for drug substance and drug product of Kite cell therapy product. + Establish user requirements for purchase, qualification of Kite's QC analytical equipment. Work with internal and external resources to maintain equipment in an optimal state. + Participate in PAI, defend regulatory audits and draft response. + Prepare of dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections. + Develop, revise and review SOPs, qualification/validation protocols and reports. + Monitor the GMP systems currently in place to ensure compliance with documented policies. + Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate. + Gather metric information for use in continuous improvement of areas of responsibility. + Perform other duties as required. **Qualifications:** + PhD molecular biologist or biochemist with 5+ years' of Quality Control experience or MS with 10+ years' of Quality Control experience in the biotech and/or pharmaceutical industry. + Well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals, preferred. + Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211) + Minimum 2 years of QC lab management experience in the biotech and/or pharmaceutical industry + Quality Control, GMPs, bioanalytical method validation + Strong knowledge of GMP, SOPs and quality control processes + Strong knowledge of technical writing for BLA, IND. + Identifying, writing evaluating and closing OOS's and investigations + Strong knowledge of cell culture techniques + Equipment and utility IQ/OQ/PQ/PV + Proficient in MS Word, Excel, Power Point and other applications + Ability to communicate and work independently with scientific/technical personnel. + Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities + Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description + Ability to think critically and demonstrate troubleshooting and problem solving skills + Excellent interpersonal, verbal and written communication skills 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:** As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 firstname.lastname@example.org for assistance. For more information about equal employment opportunity protections, please view the 'EEO is the Law' at http://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT at http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT at http://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf PAY TRANSPARENCY NONDISCRIMINATION PROVISION at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf 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. Gilead 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 log onto your Internal Career Site at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld to apply for this job. **Change The World With Us** Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and ourday-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted. While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.