Director, Quality (Clinical Laboratory)

Quest Diagnostics

Job Location:

San Juan Capistrano, CA - USA

Monthly Salary: $ 175000 - 210000

Posted on: 4 days ago

Vacancies: 1 Vacancy

Department:

Operations

Job Summary

Description

Pay range: $00 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 sitsasamemberoftheBusinessUnitsLeadershipTeamand is responsible for participating in all associated communications planning and coordination activities and works closely with Managing Director-Operations/Business/Staffing.

The position will be based at Quests San Juan Capistrano CA site and is hybrid (3 days in office).

Responsibilities

Ensurecompliancewithfederalandstatelawsandregulationsconcerninglaboratorytesting procedures and results.
OverseeandmanageoperationsforQualityAssurancetheQualityImprovementSystem State Licensure and the CA CLS Limited License Training Program.
ManagetheQualityImprovementSystemwhichincludes Root Cause AnalysisCorrectiveandPreventativeAction (CAPA) and Annual Quality Improvement Plans.
DirectinternalandexternalauditsrelatedtoISOCAPStateLaboratoryAgenciesand 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 Units 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 managersandsupervisorstoensurethattheserequirementsareimplementedandauditd
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

Bachelors Degree (Required)
Masters Degree Advanced degree in Life Sciences and Business highly desirable. (Preferred)

Licenses and Certifications

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

Work Requirements

Travel Required

Required Experience:

Director

DescriptionPay range: $00 plus yearly bonusSalary 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 ...