Senior Manager, Quality Systems (Global Process Owner)

Quest Diagnostics Incorporated•Marlborough, MA

31d•Hybrid

About The Position

Reporting to the head of Global Quality Systems, the Sr Manager- Global Process Owner (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 Change Control. 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 Capastrino, 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.

Requirements

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.
In depth knowledge of GxP, FDA, CLIA, and other relevant regulatory frameworks.
Microsoft Office 365
Proficient in Technical / Procedural Writing
Bachelor's degree in Life Sciences, Engineering, Quality, or related field.
Travel up to 25%

Nice To Haves

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
Master's Degree preferred
ASQ, ISO certification

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-Quality Management Systems 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