Senior Manager, Good Clinical Practice – Kite Pharma, Inc. – Santa Monica, CA, USA
Kite Pharma Inc. is an innovative, rapidly growing company located in beautiful Santa Monica, CA dedicated to the development and commercialization of new cancer immunotherapies with exciting early trial results. These therapies harness the power of a patient’s own immune system to fight tumor cells. We are on a rapid growth trajectory and have a highly energized and accomplished team. Kite is publicly traded (NASDAQ: KITE) with a current market well over $2 Billion.
We are seeking a highly motivated individual for the role of Senior Manager, Good Clinical Practice (GCP) Quality at Kite Pharma. The position reports to the Director, GCP Quality as part of the Quality & Operations department. This is a hands-on role where you will perform quality assurance activities to ensure that the company’s clinical trials are conducted in accordance with GCP guidelines, applicable regulations and company policies and procedures.
Responsibilities (include but are not limited to):
Leads domestic audits for Clinical Investigators and acts as the Lead Auditor Vendor Audits, Internal Process Audits and/or GCP Document Audits to ensure compliance to the Code of Federal Regulations, the International Conference of Harmonization (ICH), applicable regulations and laws and company SOPs.
Leads or participates in Systems Audits including development of audit plans and tools, managing audit conduct, and reporting the results
Obtains audit responses from company functional areas or vendors and evaluates proposed CAPAs for adequacy if implemented successfully in accordance with company SOPs
Provides interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current GCP standards.
Supports the development and refinement of the Quality Systems by leading or participating in SOP authorship or review teams.
Contributes to the development of continuous quality process improvements
Maintains current training in accordance with QA GCP training curriculum
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 ten years of experience in the biotechnology or pharmaceutical industry, with a at least 5 years in a clinical setting, either in a GCP quality role or as a Clinical Research Associate (with at least 2 years in a lead function)
Experience in performing or participating in GCP audits
Experience in clinical trials with biologics with cellular therapies a plus
Cold chain knowledge in a pharmaceutical or medical settingProficient 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% domestic travel
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 please and no agencies or recruiters.