Kite, a Gilead Company, is an innovative, rapidly growing company located in Santa Monica, CA dedicated to the development and commercialization of new cancer immunotherapies. These therapies harness the power of a patient’s own immune system to fight tumor cells.
We are seeking a highly motivated individual for the role of Manager/Senior Manager, Good Clinical Practice (GCP) Quality at Kite Pharma. The position reports to the Executive Director, Kite Quality – GCP. This is a hands-on role performing quality assurance activities to ensure that the company’s GCP activities are conducted in accordance with GCP guidelines, applicable federal regulations and company policies and procedures.
Responsibilities (include but are not limited to):
- Leads or participates in GCP audits (Internal, Clinical Sites, Third Party, Vendor, Systems) to assess compliance with GCP guidelines, applicable regulations and company policies and procedures company SOPs
- Leads or participates in Systems Audits including development of audit plans and tools, managing audit conduct, and reporting the results internally as well as externally
- Support Global Regulatory GCP Inspections
- Processes and reviews audit responses from auditees in both company functional areas and/or vendors and evaluates proposed CAPAs for adequacy if implemented in accordance with company SOPs
- Provides interpretation and guidance for internal and external customers on GCP related regulations/guidelines (FDA, ICH, EU, etc.) and company procedures and policies.
- Supports the development and refinement of the Quality Systems by leading or participating in SOP authorship and/or review teams.
- Contributes to the development of continuous quality process improvements
- Contributes quality compliance data for metrical analysis; Provide updates at daily and weekly meetings
- Other duties as assigned
- Bachelor degree or advanced degree in a scientific or related discipline
- At least five years of experience in the biotechnology or pharmaceutical industry, with a at least 2 years in a GCP compliance/quality role
- Experience in performing or participating in GCP audits
- Understanding of GCP Principles
- Experience with biologics with cellular therapies a plus
- Proficient in MS Word, Excel, Power Point and other applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- This position may require up to 30% travel