Senior Specialist, Quality Assurance

Redmond, WA

Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.

Essential Duties and Responsibilities

  • Provides the project team with interpretation and consultation on regulations, guidelines, compliance status, and policies and procedures.
  • Conducts project-specific internal and external audits (clinical trial organization, CRO, etc.) to assess quality standards and provide recommendations; prepare audit reports within a timely manner.
  • Ensures that the entire clinical trials (clinical documents and results, etc.) are conducted in adherence with the trial plan, SOPs, and ICH-GCP.
  • Reviews QA SOPs provided from CRO to ensure proper functioning of the clinical trial process.
  • Directs oversight and consults to monitors and auditors of CRO in interpretation of audit observations and formulation of corrective action plans.
  • Evaluates audit findings from CRO and prepare and distribute reports to clinical operation director.
  • Initiates audits and mock regulatory inspections, and assist in regulatory facility inspections.
  • Knows about the updates to regulations, guidelines and principles related to GCP and make recommendations for their use and compliance.
  • Willingness and ability to travel domestically and internationally as required (up to 25%).

Qualifications

Education and Experience
  • Bachelor degree or above in clinical medicine, clinical pharmacy or biology, etc.
  • Over 5 year of audit experience, CRO company experience is preferred.
  • Must have experience preforming clinical site audits (GCP).
  • Strong understanding of statistical regulatory guidance and standards (e.g., FDA, ICH and GCP).
  • Extensive experience in regulatory inspections.
  • Ability to effectively collaborate in a dynamic, cross-functional environment.
  • Good ability to work independently, communicate and solve problems.
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