Director, Quality (Clinical Laboratory)

The Director, Quality is directly responsible for coordinating and directing all functions of Quality Assurance and the CA CLS Limited License Training Program. This position assumes responsibility for ensuring that all technical and business requirements for laboratory testing are in place and maintained through the Quality Management System.

The Director, Quality sits as a member of the Business Unit's Leadership Team and is responsible for participating in all associated communications, planning and coordination activities and works closely with Managing Director-Operations/Business/Staffing. 

• Ensure compliance with federal and state laws and regulations concerning laboratory testing procedures and results.
• Oversee and manage operations for Quality Assurance, the Quality Improvement System, State Licensure, and the CA CLS Limited License Training Program.
• Manage the Quality Improvement System, which includes Root Cause Analysis, Corrective and Preventative Action (CAPA) and Annual Quality Improvement Plans.
• Direct internal and external audits related to ISO, CAP, State Laboratory Agencies and Clinical Trials.
• Ensure quality of new test validations, including Laboratory Developed Tests 
• Responsible for preparedness, the audit process, and follow-up activities.
• Ensure an effective program of Document Control is in place.
• Coordinate and approve development of scorecard metrics and goals for Business Unit.
• Prepare and maintain Management Review document
• Coordinate corporate quality and Customer directives with local procedures.
• Assure accurate and timely response to Customer Feedback and demonstrate continuous improvement to Customer Satisfaction Survey Scores.
• Ensure Training and competency requirements are defined and achieved at the Business Unit.
• Responsible for Business Unit's compliance with Clinical Trials Service Level Agreement.
• Identify and relate the quality control, quality management requirements of Quest Diagnostics Inc. and the State, Federal and other agencies to department directors, managers, and supervisors to ensure that these requirements are implemented and auditd
•  for compliance.
• Advise the appropriate supervisor, managers, or technical director, if and when requirements are not met. Inform the Medical Director of such deviations.
• Advise the Medical Director regarding the quality status of the laboratory on a regularly scheduled basis.
• Manage off-site and in-house inspections, as required.
• Assemble and maintain procedures of Quality Assurance Department.
• Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff.
• Perform other related duties are requested by the Medical Director, and/or Managing Director.

Required Work Experience:

• 10+ years in a Clinical Laboratory setting.
• 5+ years of demonstrated leadership and management responsibilities.
• 3+ years of experience in a Regulatory Environment or demonstrated knowledge in state and federal regulatory requirements.

Knowledge:

• Demonstrated knowledge in state and federal regulatory requirements.

   

Skills:

• Demonstrated skills and training in Quality Improvement.
• Excellent communication skills, verbal and written.
• Ability to work without direct supervision.

• Demonstrated ability to collaborate effectively across teams and functions.

   

People Leader Responsibility: 

• Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff.
• 4 Direct reports and 3 Indirect Reports 

Education

• Bachelor’s Degree (Required)
• Master’s Degree or PhD in Life Sciences or MBA highly desirable. (Preferred)