Manager Quality Systems

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were 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.

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Job Description

We are seeking a highly motivatedindividual who demonstrates growth mindsetto join us as Manager Quality Systems to support pipeline programs andmanagethe activities of the RDMC Quality Systems department in our Clinical Manufacturing facility located in Santa Monica CA. This position reports to the Associate Director of QA and QS at RDMC.

Responsibilities:

• ManageQuality Systems staff including recruitmentperformance management hiring along with staff training and development.
• Implement risk based and phase appropriate QMS and ensure the site maintains agility and good collaboration with Process Development and Analytical Development to reduce RFD to IND timelines.
• Provide oversight own and mature the QualityManagementReview (QMR) process. Ensure compliance with regulatory requirements and internal policies.
• Provide guidance to staff to ensure that the QualityManagementReview process arefollowed throughin a comprehensive compliant and timely manner.
• Identify KPIs for Quality Systems andreport to various tiers and governances.
• Work closely with Global Quality Systems Owners and represent site at network meetings (ChangeControls Deviation/CAPA Training Doc Control).Sharebest practices identify and implement improvements.
• Manage Doc Control and Issuance of batch records and inprocess labels for patient lots.
• ManageChangeControl process mature the process and ensurechangecontrols are assessed byrequiredfunctions andfollowed throughper plan and timeline.
• Report metrics including analysis of trends and recommendations on corrective to address repeat nonconformances. Present and escalate tostakeholdersasneeded.
• Managedeviation review board and ensureall productrelated Deviations and CAPAs are initiated investigated and resolved in a timely fashion.
• Developappropriate training material to facilitate training on quality systems.
• Quality System SME for regulatory inspections and internal audits. Provide QSsupportduring inspections.
• Review and approve quality system records asneeded.
• Ensure crosstraining and support with the QA Operations team.

Basic Qualifications:

• PHD/PharmD OR
• Masters Degree and 4yearsof relevant experience in Biopharmaceutical or BiologicsOR
• Bachelors Degree and 6yearsof relevant experience in Biopharmaceutical or BiologicsOR

Preferred Qualifications:

• Degree in the biological sciences engineering or related field.
• Demonstrated ability to think in a riskbasedmanner.
• Cell Therapy experience preferred.
• Knowledge and experience with a phase appropriate Quality Systems in a highly regulated manufacturingenvironment.
• 5yearsof prior experiencedevelopingQuality Systems group.
• 3yearsof experience managing QMRChangeReview Board and Deviation Review Boardrequired.
• Working knowledge of quality systems and regulatory requirements 21 CRF Part 11/210/211 ICH Q8 ICH Q9 ICH Q10
• Knowledge and experience with Quality System metrics trending QualityRisk Managementand Metric Control Plans.
• Understandingof aseptic manufacturing and/or cell therapy processes.
• Knowledge andunderstandingof FDA EMEA and other global regulatory compliance guidelines specific to Quality Systems.
• Skills knowledge and experience inProject Management.
• Comfortableinteractingwith regulatory agencies asneeded.
• Demonstratesexcellentverbal written and interpersonalcommunication skills.
• Demonstrated ability todevelopguide andmentordirectreports
• Comfortable in aexcitingcompanyenvironmentwith minimal direction and able to adjust workload based upon changing priorities

Does this sound like you If so apply today!

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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 longterm 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 systems ability to recognize and tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

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