Senior Manager, Quality Systems

Quest Diagnostics; Marlborough (MA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Day 1 Medical, supplemental health, >d

Best-in-class well-being programs

Annual, no-cost health assessment

401(k) pre-tax and/or Roth IRA with 5%

Employee stock purchase plan

Life and disability insurance

Annual incentive plans

Job summary

Regulatory Jobs in Marlborough, MA, is seeking a Senior Manager - Quality Systems to lead global quality initiatives, harmonize processes, and drive digital enablement across business units. Reporting to the head of Global Quality Systems, you will shape policies aligned with ISO, FDA, CLIA, and CAP, partner with regulatory affairs, IT, and operations, and mentor cross-functional teams.

This hybrid role offers a comprehensive benefits package and opportunities for career advancement in a dynamic

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Quality, or related field is required.
• Master’s degree is preferred.
• Experience in regulated healthcare environments is essential.
• Knowledge of GxP and regulatory frameworks is expected.

Responsibilities

• Support global policies, procedures, and standards in line with ISO, FDA, CLIA, CAP.
• Help develop a global roadmap for process maturity and automation.
• Monitor KPI performance and process health through dashboards and audits.
• Collaborate with Regulatory Affairs to assess new regulations and ensure compliance.
• Lead change to drive adoption of global standards across sites.
• Create training materials and role-based content for quality systems.
• Define requirements with IT and QARA teams to enable process automation.
• Support system configurations, validation, and integration projects.
• Engage with stakeholders to ensure alignment of global processes.
• Participate in inspections/audits when needed.

Skills

Microsoft Office 365

Technical/Procedural Writing

Education

Bachelor’s Degree in Life Sciences, Engineering, Quality, or related field

Master’s Degree

Tools

MasterControl

Veeva

Medialab

Smartsolve

Job description

Pay Range: $110,000 - $160,000 / year

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!

Primary location to hire: Marlborough, MA (Hybrid)
Open to someone residing close to one of our other major labs: (Pittsburgh, PA; Houston, TX Lenexa, KS; Dallas, TX; Wooddale, IL, Tampa, FL; Chantilly, VA; Clifton, NJ, San Juan Capistrano, CA)

Reporting to the head of Global Quality Systems, the Sr Manager- Quality Systems is responsible for supporting the global design, standardization, governance, and continuous improvement of core quality system processes across all business units and geographies. This position ensures that quality processes are effective, compliant, and aligned with both regulatory requirements and business objectives. The Sr Manager- Quality Systems partners cross functionally to drive harmonization, digital enablement, and operational excellence across Quest’s global quality landscape.

• Support the development of global policies, procedures, and standards in alignment with ISO, FDA, CLIA, CAP, and other applicable regulations.
• Support a global roadmap for process maturity, automation, and integration with other quality and business processes.
• Monitor performance and compliance of KPIs and process health metrics through dashboards, audits, and reviews.
• Partner with Regulatory Affairs to assess the impact of emerging regulations and ensure proactive compliance
• Serve as a change agent to drive adoption and behavioral alignment with global standards.
• Collaborate with the Global Process Owner (GPO) and develop training materials and deploy role-based training content for the quality system processes.
• Partner with GPO, IT, and QARA project management teams to define user and functional requirements and enable process automation.
• Support system configurations, validation, and integration projects that impact the quality processes.
• Engage with GPOs, Site Quality leaders, Operations, R&D, IT, Legal, and other stakeholders to ensure global process alignment and effectiveness.
• Participate in global communities of practice and user forums for continuous feedback and best practice sharing.
• Participate in corporate and/or health authority inspections/audits when local SMEs have not been able to satisfy auditor requests or questions.

Required WorkExperience:

• 8+ years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance, with at least 3 years in a regulated healthcare, life sciences, or diagnostics environment
• 3+ year of experience of global or local process ownership or project leadership experience

Preferred Work Experience:

• Experience in Quality and Regulatory Affairs within the diagnostics, medical devices, or laboratory services industry
• Working knowledge of enterprise systems such as MasterControl, Veeva, Medialab, Smartsolve, etc.
• Demonstrated ability to lead change in a regulated environment
• ASQ, ISO certification

Knowledge:

• In depth knowledge of GxP, FDA, CLIA, and other relevant regulatory frameworks

Skills:

• Microsoft Office 365
• Proficient in Technical / Procedural Writing

Education:

• Bachelor’s Degree Bachelor’s degree in Life Sciences, Engineering, Quality, or related field. (Required)
• Master’s Degree (Preferred)