Ensures development, implementation and monitoring of the Quality Plan of the Precision Medicine NGS lab and maintains regulatory compliance and monitoring processes of the lab. Responsible for the operations of orthogonal confirmation testing, which include a multitude of molecular assays, including but not limited to panel NGS, pyrosequencing, sanger sequencing, ddPCR, FISH, IHC, etc.  

Position Activities

• Regularly checks and reviews evolving requirements and guidelines from NYS CLEP NGS regulatory agencies. Interpret updated guidelines and determine how protocols need to change (if needed) to stay compliant with frequently changing landscape of the clinical NGS environment.
• Responsible for leading multi-disciplinary group to implement changes based on frequently released guidelines.  Involves implementing changes affecting upstream and downstream workflows, which may impact clinicians, laboratory staff, and institutional infrastructure (ITS).  Required to lead discussions, properly communicate impact of changes, and receive buy-in from all affected parties.
• Collects, maintains, and distributes copies of law, regulatory memoranda and accrediting information and makes judgement calls of lab protocols based on interpretation. Acts as host for all regulatory and accreditation inspections. Coordinates timely responses and maintains accurate and complete files to these activities.
• Develops, implements, and monitors the lab Quality Management system. Implements changes that will enhance the Quality Process of the lab. Writes Standard Operating Procedures and Policies to ensure compliance.
• Guides the lab staff in governmental, regulatory, and compliance matters and implements changes as needed with the input of the Directors, Managers, and Technologists.Leads the development and implementation of a comprehensive Staff Training and Competency Program. Initiates training and Educational files for staff members.
• Performs and summarizes lab audits as defined by the Lab Quality Plan. Monitors and ensures timely implementation of corrective action plans.
• Maintains Quality Standards. Provides supervision, including work direction, work assignments, and answering job-related questions.
• Maintains and tracks all Event Analysis Forms. Review records as needed. 

Performs other related duties as assigned.