Sr. Manager Good Clinical Practice (GCP) Audits and Compliance

For Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job.
Job Description Responsibilities include, but not limited to:

• Lead or participate in GCP audits (Internal, Clinical Sites, Vendors) to ensure compliance with GCP guidelines, applicable regulations and company policies and procedures company SOPs
• Lead or participate in Systems Audits including development of audit plans and tools, managing audit conduct, and reporting the results
• Obtain audit responses from company functional areas or vendors and evaluates proposed CAPAs for adequacy if implemented successfully in accordance with company SOPs
• Provide interpretation and guidance for internal and external customers on GCP related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies
• Work closely with the clinical operations teams to provide expert clinical compliance information; also work closely with other Development functions for compliance guidance/support
• Assist in inspection readiness preparation, and/or directly support regulatory agency inspections. Assist in coordination of responses to findings.
• May serve as Clinical Compliance Lead and/or Vendor Compliance lead for assigned clinical trial programs/vendors
• Contribute quality compliance data for metrics reporting and analysis
• Support the development and refinement of the Quality Systems by leading or participating quality workshops, procedural authorship and/or review, and gap analyses
• Contribute to the development of continuous quality process improvement as well as /overseeing CAPAs, or RDQMG organizational enhancements
• Other duties as assigned
• Willingness to travel; this position may require up to 30% travel domestic and/or international

Basic Qualifications

• PhD in life sciences or related discipline OR
• MS/MA in life sciences or related discipline and 6+ years of experience in Biotechnology or Pharmaceutical Industry OR
• BS/BA in life science or related discipline and 8+ years of experience in Biotechnology or Pharmaceutical Industry OR
• High School degree and 12+ years of experience in Biotechnology or Pharmaceutical Industry

Preferred Qualifications

• Bachelor’s degree or advanced degree in a scientific or related discipline
• 7+/8+ years of experience in the biotechnology or pharmaceutical industry, with at least 5-6 years of experience in a GCP compliance/quality role; depending on the candidate’s relevant knowledge/experience acquired, there could be some flexibility regarding the years of experience.
• Experience in performing and participating in GCP audits
• Proficiency in ICH GCP Guidelines and regulatory requirements for the conduct of clinical trials.
• Experience with cellular therapies is a plus
• Proficient in MS Word, Excel, Power Point and other applications
• Ability to balance multiple priorities in a fast-paced environment while delivering a timely and high-quality end work product
• Excellent interpersonal, verbal and written communication skills; working language English is a must, additional linguistic skill is a plus
• Self-directed and able to work independently with minimal direction in a fast-paced small company environment, applying judgment with limited information or guidance

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.
Equal Employment Opportunity (EEO) It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. For Current Kite Pharma Employees and Contractors: Please log onto your Internal Career Site to apply for this job.