Manager, Quality Systems

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 who demonstrates growth mindset to join us as Manager, Quality Systems to support pipeline programs and manage the 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:

• Manage Quality Systems staff including recruitment, performance 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 Quality Management Review (QMR) process. Ensure compliance with regulatory requirements and internal policies.
• Provide guidance to staff to ensure that the Quality Management Review process are followed through in a comprehensive, compliant, and timely manner.
• Identify KPIs for Quality Systems and report to various tiers and governances.
• Work closely with Global Quality Systems Owners and represent site at network meetings (Change Controls, Deviation/CAPA, Training, Doc Control). Share best practices, identify and implement improvements.
• Manage Doc Control and Issuance of batch records and in-process labels for patient lots.
• Manage Change Control process, mature the process and ensure change controls are assessed by required functions and followed through per plan and timeline.
• Report metrics, including analysis of trends and recommendations on corrective actions. Develop extensive plan to address repeat non-conformances. Present and escalate to stakeholders as needed.
• Manage deviation review board and ensure all product-related Deviations and CAPAs are initiated, investigated and resolved in a timely fashion.
• Develop appropriate training material to facilitate training on quality systems.
• Quality System SME for regulatory inspections and internal audits. Provide QS support during inspections.
• Review and approve quality system records as needed.
• Ensure cross-training and support with the QA Operations team. 

Basic Qualifications:

• PHD/PharmD OR
• Master’s Degree and 4+ years of relevant experience in Biopharmaceutical or Biologics OR
• Bachelor’s Degree and 6+ years of relevant experience in Biopharmaceutical or Biologics OR

Preferred Qualifications:

• Degree in the biological sciences, engineering or related field.
• Demonstrated ability to think in a risk-based manner.
• Cell Therapy experience preferred.
• Knowledge and experience with a phase appropriate Quality Systems in a highly regulated manufacturing environment.
• 5+ years of prior experience developing Quality Systems group.
• 3+ years of experience managing QMR, Change Review Board and Deviation Review Board required.
• 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, Quality Risk Management and Metric Control Plans.
• Understanding of aseptic manufacturing and/or cell therapy processes.
• Knowledge and understanding of FDA, EMEA and other global regulatory compliance guidelines specific to Quality Systems.
• Skills, knowledge, and experience in Project Management.
• Comfortable interacting with regulatory agencies as needed.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Demonstrated ability to develop, guide, and mentor direct reports
• Comfortable in a exciting company environment with minimal direction and able to adjust workload based upon changing priorities

Does this sound like you?  If so, apply today!

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The salary range for this position is: $123,930.00 - $160,380.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* 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 www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
 

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