Senior Specialist, Quality Systems – Dev-CAPA-EVUnited States - California - Santa MonicaQualityRegular
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.
We are seeking a highly motivated individual to join us as Sr. Specialist, Quality Systems, who will have ownership of, provide structure for, and report metrics for the Global Deviation, Root Cause Analysis, CAPA, and EV processes. The position will report to Senior Manager, Global Quality Systems and will be located at the Kite headquarters in Santa Monica, CA.
- Lead the Global Deviation/CAPA/EV Network activities and continuous improvement efforts.
- Develop, implement, and maintain procedures, business enabling guidance, work instructions, and forms to support and mature the global programs for Deviation, Root Cause Analysis, CAPA, and EV.
- Support Global Process Owner with Deviation/RCA/CAPA/EV initiatives and projects.
- Advise Corporate Functions and Kite Commercial Sites on the interpretation and execution of Deviation / Root Cause Analysis / CAPA / EV procedures.
- Deliver RCA/CAPA/EV/Technical Writing training for Corporate Functions. Assist sites as training host, or co-host as needed.
- Complete metric reports and metric follow-up actions including the monitoring of Corporate Functions and Global Deviation, CAPA, and EV records to ensure compliance to procedures in support of biweekly Tier huddles and Quarterly Management Reviews.
- Ideate analytical reports for metric reporting and deviation trending.
- Develop training materials for Deviation/RCA/CAPA/EV/Technical Writing.
- Own and/or quality approve quality management system records such as Audit, Deviation, CAPA, EV, and Change Control.
- Support regulatory inspections and internal audits as needed.
- Master’s Degree and 5+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotech, biologics, and/or cell therapy operations OR
- Bachelor’s Degree and 7+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotech, biologics, and/or cell therapy operations OR
- High School Degree and 11+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotech, biologics, and/or cell therapy operations
- Quality Systems expertise specific to Deviation, Root Cause Analysis, CAPA, EV and Trending.
- Expertise in key performance indicators to drive improvement in Quality Systems.
- Knowledge and understanding of global regulations specific to Quality Systems.
- Demonstrated skills in critical thinking and data analysis.
- Demonstrated skill in leading training and presenting to staff of all levels.
- Comfortable interacting with regulatory agencies as needed.
- Understanding of aseptic manufacturing and/or cell therapy processes.
- Excellent verbal, written, and interpersonal communication skills.
- Working knowledge of data analytical platforms such as Tableau and Spotfire.
- Working knowledge of other quality systems/processes, such as Change Control, Management Review, Risk Management, Audits/Inspections etc.
- Skills, knowledge, and experience in Project Management.
Does this sound like you? If so, apply today!