Senior Manager, Quality Good Clinical Practice – Kite Pharma, Inc. – Santa Monica, CA, USA
Develop and implement GCP quality oversight systems through development of procedures that follow 21 CFR Part 50, 56 and 312 along with ICH E6 and other relevant guidance documents
Develop and implement full clinical site qualification program through development of GCP auditing system
Participate in the development of clinical site training systems and site certifications related to cellular therapy processes
Collaborate with the Kite Clinical Operations team, CROs and sites to effectively and efficiently set up the overall GCP oversight programs
Develop and provide independent periodic reports to Kite Pharma management on overall compliance status
Assist team in the creation of personal goals and monitor performance
Provide updates at daily and weekly meetings
Other duties as assigned
Requirements:
Bachelor degree or advanced degree in a scientific or related discipline
At least eight years of experience in an industry clinical setting in a GCP quality role or as a Clinical Research Associate, with at least 2 years leading the GCP function
Experience in GCP audits either through performing audits or being the recipient of the audit
Experience in clinical trials with biologics with cellular therapies a plus
Cold chain knowledge in a pharmaceutical or medical setting
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
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of the first 100 employees in this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. Did we forget to mention the stock options? To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
No phone calls or recruiters please.
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