Director of Quality, Clinical Lab

Quest Diagnostics; San Juan Capistrano (CA); On-site; USD 175,000 - 210,000; Full time

Benefits offered by this job

Day 1 Medical

Blueprint for Wellness

Healthy Minds

Vacation and Health/Flex Time

401(k) match

Job summary

Quest Diagnostics seeks a Director of Quality in California. You will coordinate Quality Assurance, ensure compliance with federal and state laws, and oversee the CA CLS training program.

This role sits on the Leadership Team and collaborates with Operations, Business, and Staffing to drive quality improvements. Required are 10+ years in a clinical lab, 5+ years in leadership, and 3+ years in regulatory environments.

Qualifications

• Bachelor's degree required.
• 10+ years in a clinical laboratory setting.
• 5+ years of leadership/management responsibilities.
• 3+ years in regulatory environment or knowledge of regulatory requirements.

Responsibilities

• Coordinate and direct all functions of Quality Assurance.
• Lead CA CLS Limited License Training Program oversight.
• Ensure compliance with federal and state laws for lab testing.
• Manage ISO, CAP, and regulatory audits and inspections.
• Develop and implement Quality Improvement Plans and scorecards.

Skills

Quality Improvement

Communication skills

Leadership

Team collaboration

Self-management

Education

Bachelor's Degree

PhD or MS in Life Sciences/Business desirable

Job description

Pay range: $175,000-210,000, plus yearly bonus

Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.

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
• Annual, no-cost health assessment program Blueprint for Wellness
• healthyMINDS mental health program
• Vacation and Health/Flex Time
• 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!

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.

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.
• 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.

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.

People Leader Responsibility: Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff.

Education

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

Licenses and Certifications

• Current California Clinical Laboratory Scientist license. (CA Only-Required)