Senior Manager, Quality Systems
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 Senior Manager, Quality Systems to handle the activities of the plant Quality Systems department to support the startup of Kite’s brand new, state of the art, commercial Cell Therapy facility currently under construction in Frederick, Maryland.
Job Duties include, but not limited to:
- Lead Quality Systems staff including recruitment, performance management, hiring along with staff training and development.
- 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 executed in a comprehensive, compliant, and timely manner.
- Identify critical metrics for Quality Systems and develop Metric Control Plan.
- Work closely with Global Quality Systems Owners and represent site at network meetings (Change Controls, Deviation/CAPA). Share outstanding practices, identify and implement improvements.
- Establish Change Control Review Board, mature the process and ensure change controls are assessed by required functions and executed per plan and timeline.
- Report metrics, including analysis of trends and recommendations on corrective actions. Develop robust plan to address repeat non-conformances. Present and call out to management as needed.
- Establish 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.
- Bachelor’s Degree in the biological sciences, engineering or related field.
- Minimum of 10 years of relevant experience in Biopharmaceutical or Biologics. Cell Therapy experience preferred.
- Knowledge and experience in Quality Systems in a highly regulated manufacturing environment.
- 5+ years of prior experience leading 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, coach, and mentor direct reports
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
- Demonstrated ability to think in a risk-based manner.
Does this sound like you? If so, apply today!
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.