Director of Quality Assurance and Regulatory Compliance
Passionate about making a difference in the world of cancer genomics?
With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don't have the infrastructure or expertise to make sense of this data. We're on a mission to connect an entire ecosystem to redefine how genomic data is used in clinical settings. We are looking for a quality manager who will be responsible for regulatory compliance for a clinical sequencing lab.
- Build quality system compliant with CLIA, CAP, and NYS state clinical lab regulations for high-throughput NGS laboratory
- Oversee quality assurance, quality control activities, and quality management system related to laboratory operations
- Oversee the creation, implementation, and maintenance of key quality systems, including quality protocol investigation reports (CAPA, etc.), non-conformances, audit reports, protocols, regulatory submissions
- Manage internal document control system, including creation/ revision/ review of internal SOPs and other quality documentation
- Ensure performance of internal quality audits and facilitate preventative and corrective actions
- Manage internal training program and personnel documentation
- Technical review of protocols and validation summary data
- Review of software documentation
- Oversee purchasing control system
Required Knowledge and Skills
- Highly organized and systematic, superb attention to detail and ability to complete tasks with a high degree of accuracy
- Previous quality assurance/control experience in a clinical lab regulated by CAP/ CLIA/ NYS
- Bachelor’s degree required