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Senior Manager, Quality Engineering

Company: Kite Pharma
Location: Gaithersburg
Posted on: July 15, 2019

Job Description:

Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient's own immune system to selectively target and kill cancer cells. Our core technology involves the genetic engineering of T cells, to express either target-specific chimeric antigen receptors (CARs) or T cell receptors (TCRs) for the treatment of advanced solid and hematological malignancies. We are on a rapid growth trajectory and have a highly energized and accomplished team driving to new frontiers of care for cancer patients.Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!We are seeking a highly motivated individual to join us as the site lead for Quality Engineering at our Gaithersburg, MD location. The facility focuses on the development of novel T cell therapies targeting tumor mutations (neoantigens).The Senior Manager, Quality Engineering will be responsible for Computer System Validation Execution, Management and Administration and assume ownership of the related processes at the site. There is a focus on local systems to ensure compliance with Kite's corporate procedures and all applicable regulatory guidelines. The role includes support of commissioning and qualification at Kite's manufacturing site as well as providing mentorship and support to the site validation group tasked with implementation of automated equipment.Reporting to Kite's Head of Quality at this site and obtaining guidance from Global QE, you'll interface and build positive relationships with IT, Validation, Engineering, Manufacturing, R&D and other parts of Kite's organization.Responsibilities (include but are not limited to):Lead all aspects of equipment, facility, and computer system qualification/validation for Kite at the Gaithersburg site.Support the change control process for qualified/validated systems.Ensure alignment of automation system qualification with our CSV procedures.Drive computer system compliance aspects.Partner with the Global QE department around automation strategies.Support regulatory inspections and audits.Manage the quality risk management process for the site.Support vendor qualification and - compliance audits.Review technical/investigation reports as appropriate.Review and approve proposed changes to systems and procedures, as appropriate.Track, review and report metric information for use in continuous improvement of areas of responsibility.Perform other duties as required.Skills/Qualifications:Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product).Automation, equipment and utility IQ/OQ/PQ/PV.Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.Strong knowledge of GMP, GAMP, SOPs and quality systems.Experience with internal and external audit principals.Strong knowledge of change control practices/strategies.Proficient in MS Word, Excel, Power Point and other applications.Strong written and verbal communication skills.Ability to communicate and work independently with scientific/technical personnel.Requirements:Bachelor's degree in technical discipline (Biology/Chemistry/Microbiology/Computer Science/Engineering or related field) with a minimum of 8 years in a technical role in quality engineering, manufacturing, analytical testing or engineering within a biotechnology, biologics, or pharmaceutical manufacturing facilityWorking knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH Q8, ICH Q9, ICH Q10)Experience with T Cell Biology, Immunology and Immunotherapy and related equipment is preferred.Experienced in all stages of validation for systems and process. Excellent knowledge of Computerized System Validation approaches based on GAMP 5.Certified in, or has demonstrated knowledge of, six sigma.Experience in Risk Management, Change Control and CAPA systems.Following safety requirements and ensure they are met at every point in the manufacturing facility.Accepting temporary responsibilities outside of initial job description.Using verbal and written communication and technical presentation skills to collaborative in the work environment.Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.Does this sound like you? If so, please apply today!#LI-ML1IND123Kite 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 contactcareers@gilead.comfor assistance.For more information about equal employment opportunity protections, please view the'EEO is the Law'poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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 to apply for this job.

Keywords: Kite Pharma, Washington DC , Senior Manager, Quality Engineering, Executive , Gaithersburg, DC

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