Senior Manager, Quality Systems

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.

Preference will be given to someone residing close to one of our Major labs in (Pittsburgh, PA; Houston, TX Lenexa, KS; Marlborough, MA; Dallas, TX; Wooddale, IL, Tampa, FL; Chantilly, VA; Clifton, NJ, San Juan Capistrano, CA)

 

Work Schedule: Hybrid ( 3 days onsite, 2 days work from home)

 

Internal Grade: 51 

 

Preference will be given to someone with regulated healthcare, life sciences, or diagnostics background.

 

***No sponsorship available*** 

 

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:

· Medical/Prescription Drugs

· Dental

· Vision

· Flexible Spending Accounts (FSAs)

· Supplemental Health Plans

· 401(k) Plan – Company match dollar-for-dollar up to 5%

· Employee Stock Purchase Plan (ESPP)

· Supplemental Life Insurance

· Dependent Life Insurance

· Short- and Long-Term Disability buy-up

· Blueprint for Wellness

· Emotional Well-Being Resources

· Educational Assistance

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+ 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)

About the Team 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.