Director of Quality Assurance and Regulatory Compliance
3 weeks ago
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.