Senior Manager, Quality Systems (Global Process Owner)

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

Benefits offered by this job

Medical/Prescription Drugs

Dental

Vision

Flexible Spending Accounts (FSAs)

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

Employee Stock Purchase Plan (ESPP)

Paid time off / Health Time

Job summary

A leading diagnostics company in Massachusetts seeks a Senior Manager, Quality Systems to oversee global process design and compliance. The role involves developing global policies aligned with regulatory standards and driving process maturity. Candidates should have over 8 years of experience in Quality Assurance, plus strong leadership in regulated environments. This position offers a hybrid work schedule and a competitive salary range of $110,000 – $160,000 annually.

Qualifications

• 8+ years of experience in Quality Assurance, Quality Systems, or Regulatory Compliance.
• 3+ years in a regulated healthcare, life sciences, or diagnostics environment.
• In-depth knowledge of GxP, FDA, CLIA, and other relevant regulatory frameworks.

Responsibilities

• Own end-to-end global process design and performance for the assigned quality system element.
• Develop global policies, procedures, and standards in alignment with ISO, FDA, CLIA, CAP.
• Establish and drive a global roadmap for process maturity, automation, and integration.

Skills

Microsoft Office 365

Technical / Procedural Writing

Education

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

Tools

MasterControl

Veeva

Medialab

Smartsolve

Job description

Senior Manager, Quality Systems (Global Process Owner)

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

This position will serve as a Global Process Owner for Document Management and document training.

Key Details

• Work Schedule: Hybrid – 3 days onsite, 2 days work from home
• Internal Grade: 51
• Preference: regulated healthcare, life sciences, or diagnostics background
• Pay Range: $110,000 – $160,000 per year
• No sponsorship available

Benefits

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.

• 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
• Paid time off / Health Time
• Variable Compensation Plans
• Sales Incentive Plans

Responsibilities

• Own end‑to‑end global process design and performance for the assigned quality system element.
• Develop global policies, procedures, and standards in alignment with ISO, FDA, CLIA, CAP, and other applicable regulations.
• Establish and drive a global roadmap for process maturity, automation, and integration with other quality and business processes.
• Define KPIs and process health metrics; monitor performance and compliance through dashboards, audits, and reviews.
• Serve as the primary decision maker for global process‑related escalations, deviations, and change initiatives.
• Partner with Regulatory Affairs to assess the impact of emerging regulations and ensure proactive compliance.
• Lead change management efforts to drive adoption and behavioral alignment with global standards.
• Collaborate and develop training materials and deploy role‑based training content for the process.
• Partner with IT and e‑QMS project management teams to define user and functional requirements and enable process automation.
• Support system configurations, validation, and integration projects that impact the quality process.
• Serve as the approver on CSV validation documents ensuring Part 11 compliance.
• Engage with Site Quality leaders, Operations, R&D, IT, Legal, and other stakeholders to ensure global process alignment and effectiveness.
• Facilitate 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.
• Serve as owner and business system administrator of technology tool.

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 in global or local process ownership or project leadership.

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.

Required

• Bachelor’s degree in Life Sciences, Engineering, Quality, or related field.
• Travel up to 25 %.
• English required.

Preferred

• Master’s Degree preferred.
• ASQ, ISO certification.

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 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.