Director of Quality, Clinical Lab

About the role

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.

Responsibilities

• 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.
• Cook up 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 as requested by the Medical Director, and/or Managing Director.

Qualifications

• 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. Knowledge of ISO15189 standard is desirable.
• 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.
• Education: Bachelor’s Degree (Required). Master’s Degree Advanced degree in Life Sciences and Business highly desirable. (Preferred)
• Licenses and Certifications: Current California Clinical Laboratory Scientist license. (CA Only-Required)

Benefits Information

We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects – physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:

• Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours
• Best-in-class well-being programs
• Annual, no-cost health assessment program Blueprint for Wellness®
• healthyMINDS mental health program
• Vacation and Health/Flex Time
• 6 Holidays plus 1 "MyDay" off
• FinFit financial coaching and services
• 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service
• Employee stock purchase plan
• Life and disability insurance, plus buy-up option
• Flexible Spending Accounts
• Annual incentive plans
• Matching gifts program
• Education assistance through MyQuest for Education
• Career advancement opportunities and so much more!