Senior Specialist, Clinical Quality Assurance - Hybrid
Company: ImmunityBio
Location: El Segundo
Posted on: May 4, 2024
Job Description:
ImmunityBio, Inc. is a late-stage immunotherapy company
developing a broad pipeline of 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."
The U.S. Food and Drug Administration (FDA) has accepted for review
ImmunityBio's resubmission of its Biologics License Application
(BLA) for N-803, a first-in-class IL-15 superagonist, plus Bacillus
Calmette-Guerin (BCG) for the treatment of BCG-unresponsive
non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or
without Ta or T1 disease, and has set a user fee goal date (PDUFA
date) of April 23, 2024.Why ImmunityBio?* ImmunityBio is developing
cutting edge technology with the goal to transform the lives of
patients with cancer and develop next-generation therapies and
vaccines that complement, harness and amplify the immune system to
defeat cancers and infectious diseases.* Opportunity to join an
early-stage public biopharmaceutical company with a headquarters in
Southern California.* Work with a collaborative team with the
ability to work across different areas at the company.* Ability to
join a growing company with development opportunities.Position
SummaryThe Senior Specialist, Clinical Quality ensures GCP
compliance with ImmunityBio entity standard operating procedures,
ICH and US FDA regulations and guidelines, and clinical study
protocols. This position interacts cross-functionally with
functional teams in Clinical Trials which include Clinical
Operations, Regulatory, Pharmacovigilance, Medical Writing and Data
Management to ensure compliance to the GCP Quality Management
System and all applicable regulatory requirements. This role is
responsible for maintaining inspection readiness at all
times.Essential Functions
- Maintain and update the Clinical Trial Quality Management
system to be current with industry standards, guidance, and best
practices.
- Contributes to the development and review of SOPs and other
controlled documents (forms, templates, work instructions).
- Ensures compliance with SOPs and ICH GCP E6 (R2)
standards.
- Manages the incident management program through monitoring of
complaints, deviations and CAPAs.
- Schedules, plans, coordinates, and conducts vendor/supplier
audits, internal audits, compliance visits, for cause audits and
clinical trial site audits.
- Prepares required documentation to support audit activities
including audit plans, audit reports, audit certificates and
corrective action plans
- Validates accuracy of audit findings, a written audit report
and follow-up activities to assure that non-compliance issues are
addressed with satisfactory resolution.
- Reviews the final audit documents for accuracy.
- Review trial related documents e.g. protocols, protocol
amendments, ICFs, pharmacy manuals and CSRs
- Apply regulations, guidance document requirements, and study
protocol requirements to clinical trial studies.
- Participate in solving GCP compliance issues within Quality
Assurance, Clinical Operations, Regulatory Affairs, Medical
Affairs, and Pharmacovigilance.
- Support joint efforts in training on company procedures, GCP
regulations, and documentation systems to assure compliance with
company policies and regulatory standards.
- Maintain all associated QA department spreadsheets tracking of
deviations, CAPAs, complaints, audit findings, and audit files as
applicable.
- Lead development and implementation efforts for inspection
readiness at all times.
- Assists senior staff during regulatory inspections or other
audits.
- Represents QA department at internal and external meetings
supporting clinical programs.
- Performs other Quality related duties, as assigned.Education &
Experience
- Bachelor's Degree in a life sciences or engineering discipline
with a minimum of 7 years of experience in a GCP-Biologics or
Pharmaceutical environment; or Master's degree in a life sciences
or engineering discipline with a minimum of 4 years' of experience
in a GCP-Biologics or Pharmaceutical environment.
- CQA or other audit certifications are a plus.
- Prior TMF or electronic document management systems experience
is a plus.Knowledge, Skills, & Abilities
- Ability to effectively plan and organize work activities and
prioritize task completion to meet schedules and deadlines
- Strong problem solving and analytical skills with demonstrated
ability to be detail-oriented, while managing multiple projects
simultaneously.
- Demonstrated understanding and application of ICH GCP E6
(R2)
- Proficient in communication both verbal and written
- Multitasks across multiple functional areas
- Timeline focused and flexible in their work scheduling to meet
the demands of a multi-product clinical phase pharmaceutical
company.Working Environment / Physical Environment
- This is a hybrid role required to work on site 2-3 times per
week
- Flexibility in working schedule, i.e., off-hours, second shift,
weekends
- 25%-30% travel may be requiredThis position is eligible for a
discretionary bonus and equity award. The base pay range for this
position is below. The specific rate will depend on the successful
candidate's qualifications, prior experience as well as geographic
location.$120,000 (entry-level qualifications) to $150,000 (highly
experiencedThe application window is anticipated to close on 60
days from when it is posted or sooner if the position is filled or
closed.ImmunityBio employees are as valuable as the people we
serve. We have built a resource of robust benefit offerings to best
support the total wellbeing of our team members and their families.
Our competitive total rewards benefits package, for eligible
employees, include: Medical, Dental and Vision Plan Options *
Health and Financial Wellness Programs * Employer Assistance
Program (EAP) * Company Paid and Voluntary Life/AD&D,
Short-Term and Long-Term Disability * Healthcare and Dependent Care
Flexible Spending Accounts * 401(k) Retirement Plan with Company
Match * 529 Education Savings Program * Voluntary Legal Services,
Identity Theft Protection, Pet Insurance and Employee Discounts,
Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays *
Exempt Employees are eligible for Unlimited PTO * Non-Exempt
Employees are eligible for 10 Vacation Days, 56 Hours of Health
Pay, 2 Personal Days and 1 Cultural Day * We are committed to
providing you with the tools and resources you need to optimize
your Health and Wellness. At ImmunityBio, we are an equal
opportunity employer dedicated to diversity in the workplace. Our
policy is to provide equal employment opportunities to all
qualified persons without regard to race, gender, color,
disability, national origin, age, religion, union affiliation,
sexual orientation, veteran status, citizenship, gender identity
and/or expression, or other status protected by law. 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, Paramount , Senior Specialist, Clinical Quality Assurance - Hybrid, Healthcare , El Segundo, California
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