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%).
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.