Senior Manager, Quality Systems (Hybrid - open to various lab locations)

Quest Diagnostics Incorporated; Marlborough (MA); Hybrid; USD 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Day 1 Medical coverage

Dental & Vision for FT employees

401(k) with company match

Annual incentive plans

Education assistance

Career advancement opportunities

Zusammenfassung

Quest Diagnostics Incorporated in Marlborough, MA seeks a Sr Manager of Quality Systems to drive global quality processes, governance, and continuous improvement across units and geographies. You will ensure compliance with regulatory requirements and partner cross-functionally to harmonize digital enablement.

The role focuses on design, governance, and implementation of core quality systems, with collaboration across regulatory affairs, IT, and operations to enable automation and risk-based

Qualifikationen

• 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+ years of global or local process ownership or project leadership experience

Aufgaben

• 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.

Kenntnisse

Quality Systems

Regulatory Compliance

Process Ownership

Cross-functional Collaboration

Technical Writing

Ausbildung

Bachelor's Degree in Life Sciences / Engineering / Quality or related field

Master's Degree (Preferred)

Tools

MasterControl

Veeva

Medialab

Smartsolve

Jobbeschreibung

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:

• * 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.

Responsibilities

• 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.

Qualifications

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)

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Quest Diagnostics honors our service members and encourages veterans to apply.

While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.

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