QA Team Lead

Quality Assurance Team LeadWe'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.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.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 escalate 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) ORBA/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) ORAssociates 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) ORHigh 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 SystemsWorking knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standardsAbility to effectively negotiate and build collaboration amongst individualsStrong teamwork and collaborative skillsExperience 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 skillsComfortable in a fast-paced environment and able to adjust workload based upon changing prioritiesWillingness to think outside of the box and adapt best practices to a small, but growing environmentMust be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficienciesSelf-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job 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.