Director, Quality (Clinical Laboratory)

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

Job summary

Quest Diagnostics Inc. in California seeks a Director, Quality to coordinate and direct all functions of the Quality Assurance program. This role ensures laboratory testing requirements are met under the Quality Management System and collaborates with leadership to drive compliance.

The Director leads QA staff, oversees CAPA and Internal/External audits, maintains document control, and aligns with state and federal regulations. Travel may be required.

Qualifications

• Experience leading Quality Assurance in a clinical laboratory.
• Strong written and verbal communication skills.
• Ability to work with minimal supervision and cross-functional teams.
• Deep knowledge of state and federal regulatory requirements; ISO15189 desirable.

Responsibilities

• Coordinate and direct all functions of Quality Assurance.
• Oversee Quality Improvement System and CAPA.
• Manage audits and regulatory inspections.
• Ensure training and competency of QA staff.
• Prepare management review documentation.

Skills

Quality Improvement

Communication

Autonomy

Cross-functional collaboration

Education

Bachelor's Degree

Master's Degree or MBA 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
• 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!

The Director, Quality is directly responsible for coordinating and directing all functions of Quality Assurance and theCA 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 theQualityManagementSystem.

The Director, Quality sitsasamemberoftheBusinessUnit'sLeadershipTeamand is responsible for participating in all associated communications, planning and coordination activities and works closely with Managing Director-Operations/Business/Staffing.

• Ensurecompliancewithfederalandstatelawsandregulationsconcerninglaboratorytesting procedures and results.
• OverseeandmanageoperationsforQualityAssurance,theQualityImprovementSystem, State Licensure, and the CA CLS Limited License Training Program.
• ManagetheQualityImprovementSystem,whichincludes Root Cause Analysis,CorrectiveandPreventativeAction (CAPA) and Annual Quality Improvement Plans.
• DirectinternalandexternalauditsrelatedtoISO,CAP,StateLaboratoryAgenciesand 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.
• AssureaccurateandtimelyresponsetoCustomerFeedbackanddemonstratecontinuous improvement to Customer Satisfaction Survey Scores.
• EnsureTrainingandcompetencyrequirementsaredefinedandachievedattheBusiness 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,andsupervisorstoensurethattheserequirementsareimplementedandauditd
• 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.
• 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)
• Master’s Degree or PhD in Life Sciences or MBA highly desirable. (Preferred)

Licenses and Certifications

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

Work Requirements

• Travel Required