Director, Quality (Clinical Laboratory)

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

Benefits offered by this job

Medical, dental & vision coverage from Day 1

401(k) with company match

Paid vacation and holidays

Annual health assessments

Financial coaching services

Job summary

Quest Diagnostics is seeking a Director of Quality at their San Juan Capistrano, CA site. This role involves overseeing Quality Assurance, compliance with regulations, and leading the Quality Improvement System. The ideal candidate will have over 10 years of experience in a clinical lab and demonstrated management capabilities. The position includes a hybrid work schedule and a supportive employee benefits package, including medical, dental, and vision coverage.

Qualifications

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

Responsibilities

• Ensure compliance with federal and state laws regarding laboratory testing.
• Manage Quality Assurance and Quality Improvement systems.
• Direct audits related to ISO and State Laboratory Agencies.
• Ensure quality of new test validations.
• Coordinate corporate quality directives with local procedures.

Skills

Quality Improvement

Excellent communication skills

Ability to work without direct supervision

Collaboration across teams

Education

Bachelor’s Degree

Master’s Degree or Advanced degree in Life Sciences and Business

Job description

Job Description

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

Salary offers are based on relevant skills, training, experience, education, and certifications, as well as market and organizational factors. Successful candidates may be eligible for an annual performance bonus.

Benefits

• Day 1 Medical, supplemental health, dental & vision for full‑time 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

Director, Quality is directly responsible for coordinating and directing all functions of Quality Assurance and the CA CLS Limited License Training Program. The role ensures that all technical and business requirements for laboratory testing are in place and maintained through the Quality Management System. The Director sits as a member of the Business Unit's Leadership Team, participates in all associated communications, planning and coordination activities, and works closely with the Managing Director‑Operations/Business/Staffing.

Location: Quest’s San Juan Capistrano, CA site. Hybrid schedule: 3 days in office.

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, including 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 Document Control program is in place.
• Coordinate and approve development of scorecard metrics and goals for the Business Unit.
• Prepare and maintain Management Review documentation.
• Coordinate corporate quality and Customer directives with local procedures.
• Ensure 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 the Business Unit's compliance with the Clinical Trials Service Level Agreement.
• Identify and communicate quality control and quality‑management requirements of Quest Diagnostics Inc. and external agencies to department directors, managers, and supervisors to ensure implementation and audit readiness.
• Advise appropriate supervisors, managers, or technical directors 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 the Quality Assurance Department.
• Responsible for selection, retention, training, evaluation, and counseling of the Quality Assurance staff.
• Perform other related duties as requested by the Medical Director 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 of state and federal regulatory requirements.

Knowledge

• Demonstrated knowledge of 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 Advanced degree in Life Sciences and Business highly desirable (Preferred).

Licenses and Certifications

• Current California Clinical Laboratory Scientist license (Required).

Work Requirements

• Travel Required.

Equal Opportunity Employer

Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.