Specialist, Development Quality Assurance & Regulatory Compliance
Company: ImmunityBio, Inc
Location: Culver City
Posted on: November 26, 2022
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
- 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
- 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
- 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
- May conduct other Quality related duties, as
- 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
- 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
Keywords: ImmunityBio, Inc, Los Angeles , Specialist, Development Quality Assurance & Regulatory Compliance, Other , Culver City, California
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