Senior Manager, Quality Systems
Quest Diagnostics
Summary
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.
Job description
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 Work Experience: 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 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 in Life Sciences, Engineering, Quality, or related field (Required). Master's Degree (Preferred).
Requirements
- 8+ years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance
- 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
- In depth knowledge of GxP, FDA, CLIA, and other relevant regulatory frameworks
- Proficient in Technical / Procedural Writing
- Microsoft Office 365
- Bachelor's degree in Life Sciences, Engineering, Quality, or related field
Benefits
- Medical, Dental & Vision
- Well-being Programs
- Health Assessment Program
- Mental Health Program
- Vacation & Flex Time
- 6 Holidays plus MyDay
- Financial Coaching
- 401(k) Matching
- Roth IRA
- Employee Stock Purchase Plan
- Life & Disability Insurance
- Flexible Spending Accounts
- Annual Incentive Plans
- Matching Gifts Program
- Education Assistance
- Career Advancement Opportunities
Company overview
Quest Diagnostics is a leading provider of diagnostic information services, operating one of the largest clinical laboratory networks in the United States. Founded in 1967 and headquartered in Secaucus, New Jersey, the company offers a comprehensive range of diagnostic testing services including routine blood tests, genetic testing, molecular diagnostics, and anatomic pathology. Quest serves approximately one-third of American adults and physicians annually through its network of approximately 2,250 patient service centers and extensive outreach operations. The company processes over 500,000 test requests daily, providing critical data that helps healthcare providers make informed decisions about patient care. Quest Diagnostics has been at the forefront of diagnostic innovation, developing advanced testing capabilities for cancer, cardiovascular disease, infectious diseases, and neurological disorders. The company plays a vital role in public health through its participation in disease surveillance and population health management initiatives.