Quality Director - Genetics

Description : Job Summary :

Leads quality assurance for both molecular genetics lab and cytogenetics lab. Assists the managing director in clinical and technical operation.

Directs and manages the day-to-day quality operations of their specific area of responsibility which includes all personnel activities, technical oversight, general workflow and budget.

Ensures compliance with applicable regulatory bodies including of federal, state, professional organization, and local requirements.

Essential Responsibilities :

Oversees quality assurance and regulatory compliance across the laboratory. Collaborates with laboratory operations leadership and coaches section managers and Sr.

Technologists regarding QA and QC.

• Assists the managing director in clinical and technical operation. Collaborates with regional lab QA leadership for projects and integration.
• Directs and manages the day-to-day quality operations for a major clinical laboratory department or multiple sections.
• Recruits, hires, trains, and ensures competency of QA team staff. Motivates and encourages professional growth.
• Participates in the design and evolution of Regional Laboratory and Northern California Region integrated laboratory quality system.
• Performs risk assessment and implements effective risk control process.
• Researches / resolves client quality related problems / issues. Assists with Root Cause Analysis in operational areas.
• Oversees and coordinates quality requirements for assay validation, technical transferring, clinical lab implementation.
• Participates in department, inter-department, inter-facility and inter-regional projects which help the Regional Laboratory achieve its goal of providing quality service and client support in a cost effective manner.
• Oversees deviation management processes.
• Serves as primary quality liaison to TPMG IT, LIS Support systems and KPIT for ongoing and new issues.
• Performa quality gap analyses as appropriate.
• Coordinates quality assurance for the integration of laboratory information systems.
• Hosts licensing and accreditation assessments; compiles and manages responses to any agency deficiencies identified.
• Interacts with TPMG Regional Quality and Compliance.
• Performs or coordinates interim self-assessment processes and activities.

Basic Qualifications : Experience

• Minimum five (5) years of experience in a high-volume clinical laboratory required.
• Minimum three (3) years of experience in a supervisory / managerial position required.

Education

Bachelors degree in clinical scientific, laboratory, or related field required.

License, Certification, Registration

Limited Specialty License (California) OR Clinical Laboratory Scientist License (California)

Additional Requirements :

• Knowledge of federal, state, local, and accreditation and licensing agency regulations.
• Practical experience in CLIA / CAP application, inspection, and quality management.
• Must be able to work in a Labor / Management Partnership environment.

Preferred Qualifications :

• Certification in quality auditing or quality engineering preferred.
• Masters degree in clinical scientific, laboratory, or related field preferred.
30+ days ago