ImmunityBio (formerly NantCell) develops novel combinations of chemo-immune sensitizers, cell therapies, cytokines, vaccines, neoepitopes, and monoclonal antibody immunotherapies to orchestrate the NK and T Cell response for cancer and infectious diseases.
Lead, Clinical Quality Assurance
PURPOSE AND SCOPE OF POSITION:
The Lead, Clinical Trials Quality Assurance role ensures GCP compliance with Nant 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.
The successful candidate demonstrates knowledge of GCP-ICG GCP E6 (R2)/(R3), is proficient in communication (written and verbal), multitasks across multiple functional areas, is a timeline focused, and flexible in their work scheduling to meet the demands of a multi-product clinical phase pharmaceutical company.
DUTIES AND RESPONSIBILITIES:
- 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).
- Assure compliance with SOPs and ICH GCP E6 (R2)/(R3) standards.
- Manages the incident management program through monitoring of complaints, deviations, and CAPAs.
- Independently 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
- Accountable for the accuracy of audit findings, a written audit report, and follow-up activities to assure that non-compliance issues are addressed with a 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.
- Leads efforts in the development and implementation of 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.
- Strong communication skills (written and verbal), to serve as a resource regarding interpretation and application of quality requirements, concepts, and industry best practices within Nant.
- Provides upper management with QA, technical and department metrics on a monthly bases. Oversees the development of QC departmental strategies and objectives.
REQUIRED COMPETENCIES (KNOWLEDGE, SKILLS, AND EXPERIENCE):
- Bachelor’s Degree in life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment.
- Experience in managing staff, a minimum of 2 years of leadership experience preferred.
- Complete understanding and application of ICH GCP R2.
- CQA or other audit certifications is a plus.
- 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.
- Knowledge of TMF or electronic document management systems is a plus.
- Flexibility in working schedule, i.e. off-hours, second shift, weekend.
- 25%-50% travel may be required.