Clinical Quality Assurance contract- Director level
Location: San Francisco, CA
Hybrid role, 2 days a week onsite
Status: Contract 20-30 hours per week
Direct experience working with small molecules is a prerequisite for this role. Biologics, large molecule, or any other experience cannot be considered at this time.
The ideal candidate for the Clinical Quality Assurance (CQA) contractor position must excel in a fast-paced, innovative environment, demonstrating flexibility, proactivity, resourcefulness, and efficiency.
This position is a hands-on role tasked with ensuring that sponsored clinical trials comply with applicable GCP regulations (e.g., FDA, international, country-specific), ICH guidelines, Standard Operating Procedures (SOPs), and current industry standards and practices.
Responsibilities
- Represent clinical quality at the program team meetings and provide operational quality guidance to the development teams.
- Represent clinical quality at CROs operational meetings, service provider meetings, and service/vendor quality meetings.
- Provide quality oversight of the ongoing clinical programs, ensuring that the appropriate assessment and monitoring, risk assessment and risk mitigations are in place.
- Review clinical trial documentation for data integrity and compliance with Good Clinical Practice and regulations including key clinical and IND/NDA enabling documents.
- Provide clinical quality support for Health Authority Inspections, service providers and CROs operational meetings, as well as inspection readiness activities.
Qualifications
- Bachelor’s degree required, advanced degree in a scientific field preferred. Quality assurance professional certification is a plus.
- At least 5 years of experience in Clinical Quality Assurance or Clinical Operations.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E6 (R2) for Good Clinical Practice. Experience with all phases of clinical trials.
- Bachelor’s degree required with 12+ years’ experience. Advanced degree in a scientific field preferred. Quality assurance professional certification is a plus.
Total compensation plan includes benefits, with possible equity, relocation assistance, and annual target bonus.
