Title: Manager, Clinical Quality Assurance
Location: Menlo Park, CA
Forty Seven Inc. is committed to helping patients defeat their cancer. We are advancing immune-oncology through the engagement of new and complementary phagocytic pathways that enhance anti-tumor efficacy and selectivity.
The CQA Manager is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) related quality assurance activities. This position performs quality assurance (QA) activities related to FDA and other associated regulations across therapeutic areas and provide GCP guidance for all phases of drug development. This position will report to the Director, Clinical Quality Assurance.
These may include, but are not limited to, the following; other duties may be assigned
- Maintain elements of QA systems, including the creation/revision of appropriate SOPs, Deviations, CAPAs, Audits/metrics and development of quality management plans
- Schedule and maintain internal and external audit plans.
- Conduct/manage routine and for cause audit of investigator site, vendors and internal audits.
- Review key documents such as study protocols, informed consent documents, investigator brochures, clinical study reports, etc.
- Lead and manage GCP Quality issues and investigations
- Represent GCP QA in clinical operations subteams and other functional team meetings.
- Active participation in regulatory inspection readiness activities
- Provide GCP guidance and interpretation of GCP regulations, as required.
- Other duties as assigned
Education & Experience:
- BS/BA with at least at least 5-7 years of related experience in Biotech/Pharmaceutical industry required.
- QA experience in a GCP setting for all phases of clinical trials.
- Minimum 2 years of direct audit experience at clinical investigator sites, GCP vendors who provide clinical trial and non-clinical study services, and internal GCP processes and documents.
- Ability to analyze and resolve complex problems, situations or data.
- Attention to detail, excellent review skills and ability to organize and manage multiple tasks in a fast paced environment
- Knowledge of FDA GCP and ICH regulations, guidelines and standards applicable to the conduct of clinical trials
- Working knowledge of pharmacovigilance guidelines desired
- Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
- Position may require occasional evening and/or weekend commitment
- Position may require working with biological and/or chemical hazards
- Position may require occasional travel (~25%), domestic and international