Vice President, Lab Quality

Regulatory Toolkit

Secaucus (NJ)

Hybrid

USD 300,000 - 350,000

Full time

12 days ago

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Benefits offered by this job

401(k) with company match
Annual incentive plan
Long-term incentive program
Career advancement opportunities
Comprehensive health benefits

Job summary

Quest Diagnostics is seeking a Vice President of Lab Quality to partner with regional leaders and report to the Chief Quality Officer. You will lead strategic quality and regulatory programs across traditional and esoteric labs, driving compliance with CAP/CLIA, FDA, and ISO standards while enhancing patient care and enterprise quality alignment.

This hybrid role requires proximity to a Quest Diagnostics hub and extensive travel.

Qualifications

  • Bachelor's degree in a scientific, life sciences, or engineering-related field is required.
  • An advanced degree (master's/PhD) is preferred.
  • Demonstrated minimum of 15 years of progressive leadership experience in quality assurance and regulatory compliance.
  • Minimum of 7 years in a senior quality leadership role with a proven track record.
  • Expert knowledge of CAP/CLIA, FDA, and ISO regulations; strong QMS, risk management and CI knowledge.

Responsibilities

  • Develop and execute a global quality strategy for traditional labs aligned with business objectives.
  • Ensure regulatory compliance with CAP/CLIA, FDA, ISO, and other standards; support inspections.
  • Provide leadership to regional quality teams to ensure consistent quality practices.
  • Drive adoption of Quest harmonized global enterprise processes including the Quality Policy.
  • Collaborate with R&D, safety, manufacturing, and supply chain to embed quality across the lifecycle.
  • Lead a culture of continuous improvement; leverage data analytics to improve test quality and efficiency.

Job description

The Vice President of Lab Quality is the business partner to Regional Presidents while reporting to the Chief Quality Officer, providing strategic leadership and oversight for quality and regulatory compliance functions across the traditional & esoteric laboratories. This executive role is responsible for ensuring that all tests and services meet and exceed customer expectations and regulatory requirements.

The VP of Lab Quality will drive a culture of continuous improvement and will be responsible for the development and implementation of a global quality management system aligned with the overall Quest Quality System Elements and Core Processes. This role will have shared responsibility for quality across all regional labs and ensure compliance with CAP/CLIA regulations. The VP of Lab Quality will also have dotted-line reports from other business units to ensure enterprise-wide quality alignment.

This is a hybrid role, and the selected candidate must be near site to one of Quest Diagnostics hub locations. Preferred locations are Clifton, NJ, Marlborough, MA; Chantilly, VA; Lenexa, KS; Tampa, FL; Irving, TX; Wood Dale, IL.

Pay Range: $300,000-$350,000/year + 40% Annual Incentive Plan + Long-Term Incentive.

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!
  • Strategic Leadership: Develop and execute a global quality strategy for the traditional labs that align with the company's overall business objectives. Communicate a clear vision for quality excellence and foster a culture of quality throughout the traditional lab organization.
  • Regulatory Compliance: Ensure compliance with all applicable regulatory requirements, including CAP/CLIA, FDA, ISO, and other international standards. Serve as a primary contact for regulatory agencies and support all regulatory inspections and audits for the traditional labs.
  • Regional Oversight: Provide leadership and guidance to regional quality teams to ensure consistent application of quality standards and procedures across all locations.
  • Ensure adoption and execution to all Quest harmonized global/enterprise processes including the Quality Policy.
  • Cross-Functional Collaboration: Work closely with other departments, including R&D, medical safety, pharma & Diagnostics, manufacturing, and supply chain, to ensure that quality is built into all stages of the product lifecycle.
  • Continuous Improvement: Drive a culture of continuous improvement throughout the organization. Utilize AI and data analytics to identify and implement best practices, and improvements to advance test quality, reduce costs, and increase efficiency.
  • A bachelor's degree in a scientific, life sciences, or engineering-related field is required. An advanced degree (master's/PhD) is preferred.
  • A minimum of 15 years of progressive leadership experience in quality assurance and regulatory compliance in the diagnostics industry, commercial/clinical laboratory industry, etc.
  • A minimum of 7 years of experience in a senior quality assurance and regulatory compliance leadership role with a proven track record of success.
  • Expert knowledge of CAP/CLIA, FDA, and ISO regulations is required. A strong understanding of quality management systems, continuous improvement methodologies, and risk management are also required.
  • Excellent leadership, communication, and interpersonal skills are essential. The ability to think strategically and to influence and motivate others is also critical for success in this role.
  • Lead and mentor a high-performing team of 8-10 quality professionals at the Regional and/or BU-level. Provide coaching, development, and performance management to ensure that the team has the skills and resources needed to succeed.
  • Must be able to travel up to 50% domestically, with some international travel required as well.
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