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Specialist, Development Quality Assurance & Regulatory Compliance

Company: ImmunityBio, Inc
Location: Culver City
Posted on: November 26, 2022

Job Description:

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory."POSITION SUMMARY: The Specialist, Development Quality Assurance (DQA) & Regulatory Compliance is responsible for activities involving quality assurance and regulatory compliance with applicable regulatory requirements such as GCP, ICH, and US FDA regulations and guidelines.This position interacts cross-functionally across the ImmunityBio organization.The successful candidate demonstrates knowledge of ICH GCP E8 (R1), is proficient in communication (written and verbal), multitasks across multiple functional areas, is timeline focused and flexible in their work schedule to meet the demands of a multi-product clinical phase bio-pharmaceutical company that is transitioning to the commercial phase.ESSENTIAL FUNCTIONS

  • Assist with the development, implementation, and maintenance of the Audit and Inspection Management program for compliance with current regulatory requirements and standards, which includes conducting mock inspections, internal auditing, inspection preparedness, and hosting/responding to external/regulatory inspections.
  • Partner throughout the ImmunityBio organization for external inspections, including driving inspection preparations, inspection management, development of audit responses, corrective actions, effectiveness monitoring, and tracking commitments to closure.
  • Facilitates operational mechanisms that may include inspection preparation meetings, audit/inspection response and commitment tracking, etc.
  • Tracks and trends metrics associated with audits/inspections and provides reports to management. Provides and may execute suggested remediation activities.
  • Works closely with the DQA functional teams to implement effective inspection readiness and preparedness programs.
  • Contribute to the development, implementation, and maintenance of the Quality Risk Management program for compliance with current regulatory requirements and standards in GCP.
  • Support the implementing the ICH GCP E8 (R1) program at ImmunityBio which focuses on critical to quality factors/metrics and achieves fit-for-purpose data quality.
  • Provide support for Subject Matter Expert (SME) for Quality Risk Management and the Quality Improvement Programs during audits and inspections.
  • May conduct other Quality related duties, as assigned.EDUCATION/EXPERIENCE REQUIREMENTS
    • Bachelor's Degree in a life sciences or engineering discipline with a minimum of 3 years of experience in a GCP-Biologics or Pharmaceutical environment; or a Master's degree in a life sciences or regulatory discipline with a minimum of 1 years' of experience in a GCP-Biologics or Pharmaceutical environment.
    • Experience in 21 CFR - Part 312, Part 50, Part 54, Part 56, Part 58 if applicable , Part 314, Part 11 and other applicable regulations.
    • Complete understanding and application of ICH GCP E8 (R1).
    • Relevant industry Pharmaceutical, Biotechnology Clinical Trials, and Quality operations experience.
    • Strong problem solving and analytical skills with demonstrated ability to be detail oriented; while managing multiple projects simultaneously.REQUIRED COMPETENCIES - KNOWLEDGE, SKILLS, ABILITIES
      • Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
      • Ability to support onsite inspections and go into the office location as needed and required.
      • Knowledge of Trial Master File (TMF) or Electronic Data Capture (EDC) systems is a plus.
      • Flexibility in working schedule, i.e., off-hours, second shift, and weekend work may be required.
      • 25%-30% travel may be required. All hires are based upon completion and passage of a background check.ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

Keywords: ImmunityBio, Inc, Los Angeles , Specialist, Development Quality Assurance & Regulatory Compliance, Other , Culver City, California

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