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Specialist III, Good Pharmacovigilance Practice (GVP) Quality and Compliance

United States - California - Santa MonicaQualityRegular

Job Description

We are seeking a highly motivated individual for the role of Specialist III, Good Pharmacovigilance Practice (GVP) Quality and Compliance at Kite Pharma. This is a hands-on role where you will perform quality assurance activities to ensure that the company’s Pharmacovigilance activities are conducted in accordance with GVP guidelines, applicable regulations and company policies and procedures.

Job Responsibilities:

  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
  • Perform internal and external pharmacovigilance audits (Internal, Affiliate, Third Party, Vendor, Systems) and compliance assessments including Risk Evaluation & Mitigation Strategies (REMS) audits to ensure compliance with GVP guidelines, applicable regulations and company policies and procedures
  • Supports the end to end processes related to the planning, conduct and reporting of GVP and REMS audits
  • Supports QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met
  • Implements and maintains programs and processes to ensure high quality products and compliance with current Good Pharmacovigilance Practices (GVPs)
  • Supports the development, review, and revision of audit plans and tools, SOPs, guidelines, and other documents
  • Support effectiveness checks and CAPAs
  • Assists with inspection readiness activities for regulatory authority inspections and supports tracking of document requests, responses, and supporting documents during inspection
  • Assists with preparing, managing, and supporting Kite teams during third party audits of Kite
  • Provides basic interpretation and guidance for internal and external customers on GVP related regulations / guidelines (FDA, ICH, EU, etc.) and company procedures and policies
  • Contributes to the development of continuous quality process improvements
  • Support the maintenance of quality compliance data and audit metrics
  • Up to 40% domestic/international travel

Basic Qualifications:

  • Master’s degree with 3+ years of in a GCP/GVP related field OR
  • Bachelor’s degree with 5+ years of GCP/GVP related field related field OR
  • High School Diploma with 9+ years of experience in a GCP/GVP field

Preferred Qualifications:

  • Knowledge of global ICH GCP, GVP, FDA, EMA guidelines and regulations
  • Demonstrates knowledge of QA principles, compliance and audit concepts, industry practices, and standards
  • Demonstrates audit and investigation skills, and report writing skills
  • Experience with project management, preparing presentations, and operational excellence
  • Proficient in Microsoft Office Suite and other applications
  • Demonstrates interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities