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 Director of Quality Assurance and Regulatory Compliance who will successfully manage, guide and implement initiatives for all aspects of quality, inspections, training, and regulatory compliance.
What you’ll do:
- Direct and manage the Quality Assurance department.
- Build quality system compliant with CLIA, CAP, and NYS state clinical lab regulations for high-throughput NGS laboratory.
- Oversee quality assurance and quality control activities related to laboratory operations.
- Oversee the creation, implementation, and maintenance of key quality systems, including corrective and preventative actions, non-conformances, audit reports, protocols, regulatory submissions, training, complaints, and document control.
- Create key quality metrics for tracking and trending critical KPI quality data.
- Ensure that all new and revised SOPs are maintained and all staff are trained accordingly.
- Conduct internal audits to ensure that compliance procedures are followed.
- Host and/or support onsite audits and ensure appropriate and sustainable action plans are developed and implemented.
- Collaborate cross-functionally with internal departments on strategy and implementation of quality principles and regulation requirements.
- Management Representative of Quality Management Review meetings
- Assess product, compliance, or operational risks and develop risk management strategies.
- Promote quality culture throughout the organization.
- Perform other essential tasks, projects, and responsibilities as assigned.
- Highly organized and systematic, superb attention to detail and ability to complete tasks with a high degree of accuracy
- Ability to lead, influence, create and work within cross-functional team environments
- Previous quality assurance/quality control experience in a clinical lab regulated by CAP/ CLIA/ NYS
- Knowledge of applicable medical device regulations and standards, e.g. 21 CFR 820, 801, 803, 806, European and Canadian medical device regulations, ISO 13485, ISO 9001.
- Minimum of 10 years of quality management experience
- Bachelor’s degree required