JOB DESCRIPTION
The Vice President, Quality, Pharma & Diagnostics, reporting to the Chief Quality Officer (CQO), is a high-impact executive leadership role responsible for the architecture and execution of the enterprise Quality Assurance strategy for our pharmaceutical and diagnostic business units. This executive serves as the primary "quality thought leader," partnering with the Senior Management Team on global regulatory shifts (FDA, ISO, and international bodies) and mitigating complexcompliance risks for medical devices and companion diagnostics.
The VP will champion a "quality first" culture across all global sites, ensuring that Quality Management Systems (QMS) are not only compliant but also serve as a competitive advantage through scalability and integration with Quest92s harmonized enterprise processes.
This is a hybrid role and the selected candidate must be near-site to one of Quest Diagnostics hub locations. Preferred locations are Chantilly, VA; Clifton, NJ; San Juan Capistrano, CA; or Secaucus, NJ.Pay Range: $300,000-$350,000/year + 35% 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 96 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!
JOB RESPONSIBILITIES
Strategic Leadership & Governance
Enterprise Strategy: Develop and implement the enterprise Quality Assurance strategy for pharma and diagnostic teams in strict alignment with corporate objectives.
Executive Advisement: Serve as the key business partner to senior leadership on FDA, ISO, and international regulatory trends and compliance risks for medical device and companion diagnostics.
Quality Culture: Establish and maintain a 92quality first92 culture across all functions and global sites, engaging senior and functional leaders in shared accountability.
Governance & Resourcing: Define organizational responsibilities and authorities; ensure independence of personnel performing quality work and guarantee resource adequacy to sustain the QMS.
Management Review: Oversee andconduct executive-level management reviews toevaluate Pharma & Diagnostic QMS performance, effectiveness, and continuous improvement.
Corporate Commitment: Demonstrate and cascade top management92s commitment to patient safety, regulatory compliance, and product quality.
Lead all Quality for the Pharma Services & Diagnostics business including clinical audit team that serves as the link between the lab92s technical operations, clinical teams, and regulatory bodies.
Regulatory Compliance & QMS Harmonization
Regulatory Oversight: Ensure uncompromising compliance with FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971, MDSAP, and other applicable global regulations.
Policy Architecture: Establish Pharma & Diagnostic global policies. Provide strategic input to the Central Quality team to ensure core processes incorporate specialized pharma and diagnostic requirements.
System Integrity: Safeguard the integrity of the QMS during organizational changes and oversee the implementation of harmonized processes for medical devices.
Audit & Inspection Readiness:Provide executive oversight for internal audits, CAPA, and regulatory inspections for pharma and diagnostic related audits. Serve as the primary executive point of contact for the FDA, Notified Bodies, and other regulatory agencies.
Global Execution: Ensure adoption and execution of all Quest harmonized global/enterprise processes, including the Corporate Quality Policy.
Product Quality & Cross-Functional Collaboration
Lifecycle Quality: Oversee product quality assurance and systems, ensuring robust processes for design controls (including Software as a Medical Device - SaMD) and post-market surveillance.
Strategic Due Diligence: Lead Quality Reviews for M&A activity, assessing medical device products and quality systems of target companies and developing integration quality plans.
Enterprise Partnership: Collaborate with R&D, Medical Quality, Lab Operations, Legal, and Supply Chain to drive adherence to global regulations for devices.
Post-Market Governance: Provide executive governance for nonconformances and partner with Complaint Handling for investigations into MDRs, Corrections, Recalls, and Removals. Implementing the appropriate post-market surveillance (PMS) program to ensure a robust corrections/recalls/removal system.
JOB QUALIFICATIONS
Required WorkExperience:
Knowledge:
Leadership Experience:
Education:
Other:
