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Compliance Specialist, Audit Coordination and Management

United States - California - Santa Monica, United States – RemoteRegulatoryRegular

Job Description

We are seeking a highly motivated individual for the role of Compliance Specialist, Audit Coordination and Management at Kite Pharma. This is a hands-on role where you will perform quality assurance activities to support all Audit Management and Audit Coordination for the Research and Development Quality and Medical Governance (R&D Q&MG) team.

Job Responsibilities:

  • Provides support to Kite R&D Q&MG Audit and CAPA for coordination as well as compliance and monitoring activities
  • Support R&D Q&MG Audits within the QMS system
  • Distribute audit notices/remote feasibility assessment, schedule interviews and distribute documents and obtain compliant electronic signatures, data entry for observation and audit responses, generating and attaching audit documents
  • Coordinate with Auditors to ensure timely receipt of audit reports and responses
  • Issue and distribute Audit reports
  • Support activities for any outsourced audits CAPA Coordination
  • Schedule meetings and track task progress through completion including documentation/data entry in GTrack
  • Compliance Monitoring: Distribute quarterly monitoring data requests and collate all data received into spreadsheets and presentations
  • Run reports and develop metrics for audits and audit responses
  • Provide training on the audit management and coordination process
  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
  • Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined audit management quality objectives are met
  • Support the development, review, and revision of SOPs, guidelines, and other procedural documents as needed
  • Support and participate in regulatory authority inspections: preparation, planning, and conduct
  • Support developing and tracking responses to completion for regulatory inspections
  • Contributes to the development of continuous quality process improvements

Basic Qualifications:

  • Master’s degree with 2+ years of experience in a GCP/GVP/GLP/Regulatory field OR
  • Bachelor’s degree with 4+ years of experience in a GCP/GVP/GLP/Regulatory field OR
  • AA degree with 6+ years of experience in a GCP/GVP/GLP/Regulatory field OR
  • High School Diploma with 7+ years in a GCP/GVP/GLP/Regulatory field

Preferred Qualifications:

  • Knowledge of global ICH GCP, FDA, EMA guidelines and regulations
  • Demonstrates knowledge of internal audit processes, industry audit management and coordination practices
  • Prior audit management experience preferred
  • REMS experience preferred
  • Experience with project management, preparing presentations, and operational excellence
  • Prior quality management experience
  • Proficient in Visio, 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

(This role can be Remote or Santa Monica based.)