Talent.com
Senior Manager, Quality Systems (Global Process Owner)
Senior Manager, Quality Systems (Global Process Owner)Quest Diagnostics • Marlborough, MA, US
Senior Manager, Quality Systems (Global Process Owner)

Senior Manager, Quality Systems (Global Process Owner)

Quest Diagnostics • Marlborough, MA, US
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
  • [job_card.part_time]
[job_card.job_description]

Sr Manager- Global Process Owner (GPO)

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.

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

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-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
  • 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 in 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
  • Required :

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

    [job_alerts.create_a_job]

    Senior Manager Quality • Marlborough, MA, US

    [internal_linking.related_jobs]
    Quality Engineer

    Quality Engineer

    Leonardo DRS • Fitchburg, MA, United States
    [job_card.full_time]
    The Leonardo DRS Naval Power Systems business is a trusted provider of innovative naval gas and hybrid power systems, control technology and support solutions for the U. Navy and navies around the w...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Controls Engineer

    Senior Controls Engineer

    Dephy, Inc. • Boxborough, MA, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    Dephy is looking for a candidate who was born to be an engineer : someone that has an urge to understand how things work, and who gets excited when there is no known solution to the problem at hand....[show_more]
    [last_updated.last_updated_30]
    Senior Production Manager

    Senior Production Manager

    Acreage Holdings • Sterling, MA, US
    [job_card.full_time]
    The Botanist is a subsidiary of Canopy USA, LLC, a leading vertically integrated, multi-state operator in the United States cannabis industry. With the transition of Acreage Holdings to Canopy USA, ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Product Development Program Manager, Ground Encryptor

    Product Development Program Manager, Ground Encryptor

    Viasat • Marlborough, MA, United States
    [job_card.full_time]
    At Viasat, we're on a mission to deliver connections with the capacity to change the world.For more than 35 years, Viasat has helped shape how consumers, businesses, governments and militaries arou...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Manager

    Quality Manager

    Consigli Construction • Milford, MA, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    Regional Quality Manager .The Quality Manager (QM) will collaborate with several project teams throughout the lifecycle of their assigned projects. Their main responsibility is to support and b...[show_more]
    [last_updated.last_updated_30]
    Indirect Global Category Manager - Quality, Regulatory, Lab Services

    Indirect Global Category Manager - Quality, Regulatory, Lab Services

    Zimmer Biomet Holdings • Worcester, MA, US
    [job_card.full_time]
    At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward.As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced by ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Process Engineer, Onsite

    Senior Process Engineer, Onsite

    AbbVie • Worcester, MA, US
    [job_card.full_time]
    AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkab...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Process Engineer

    Process Engineer

    RoslinCT • Hopkinton, Massachusetts, United States
    [job_card.full_time]
    We are a leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Join a company where collaborative, dedicated, ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Manager, Mold Maintenance

    Manager, Mold Maintenance

    Mauser Packaging Solutions • Leominster, MA, US
    [job_card.full_time]
    As a Tool Room Manager at Mauser, you will repair and maintain plastic injection molds.In the course of your work, you will use hand tools and power tools, including mills, lathes, grinders, and al...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Process and Validation Engineer

    Process and Validation Engineer

    Avantor • Devens, MA, United States
    [job_card.full_time]
    Process and Validation Engineer.The Process Engineer implements process improvements to meet quality standards, designs and conducts feasibility studies, and solves problems.This role will be a ful...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Lab Manager

    Quality Lab Manager

    Hutchinson Aerospace & Industry • Hopkinton, MA, United States
    [job_card.full_time]
    As the Quality Lab Manager, you will be at the forefront of our commitment to excellence.You will lead a talented team of Quality Technicians and Mechanical Inspectors in ensuring that all products...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Director

    Quality Director

    Producto Group • Shirley, MA, US
    [job_card.full_time]
    The Quality Director is responsible for leading all aspects of the company’s quality management program, including inspection, testing, quality assurance, and continuous improvement over 3 ma...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Supplier Quality Engineer

    Senior Supplier Quality Engineer

    LG Energy Solution Michigan, Inc. • Westborough, MA, US
    [job_card.full_time]
    Senior Supplier Quality Engineer.Remote - must reside in the Arizona area.LG Energy Solution Vertech, Inc.LGES Vertech) is a full-service energy storage system supplier and integrator.Using our cor...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Quality Engineer

    Senior Quality Engineer

    Diamond Antenna and Microwave • Littleton, MA, US
    [job_card.full_time]
    The Senior Quality Engineer II will assist the Quality Manager relating to activities such as returns, source inspection, other support as required, and maintain Quality Management System objective...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Quality Manager

    Quality Manager

    Element Materials Technology • Boxborough, Massachusetts, United States
    [job_card.full_time]
    Element has an opportunity for an experienced quality professional to join its team as a.Boxborough, Ma; Pittsfield, Ma : and Montreal, Quebec. Salary : $100,000 - $120,000 / yr DOE.Maintenance of and d...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Technical Support & Field Quality Manager

    Technical Support & Field Quality Manager

    Bose Professional • Hopkinton, MA, US
    [job_card.full_time]
    [filters_job_card.quick_apply]
    Bose Professional is a leader in the professional audio industry, specializing in the design and manufacturing of cutting-edge audio solutions including loudspeakers, amplifiers, signal processing ...[show_more]
    [last_updated.last_updated_30]
    Quality Manager

    Quality Manager

    Element • Boxborough, MA, US
    [job_card.full_time]
    Element has an opportunity for an experienced quality professional to join its team as a Quality Manager over-seeing the quality systems of Boxborough, Ma. Pittsfield, Ma : and Montreal, Quebec.Sala...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director of Data Governance and Quality

    Director of Data Governance and Quality

    Jobot • Worcester, MA, United States
    [job_card.full_time]
    Empower Paper Mills with Smarter Solutions — Join Us as an Application Sales Engineer Driving Performance and Growth!.This Jobot Job is hosted by : Robert Donohue. Are you a fit? Easy Apply now by cl...[show_more]
    [last_updated.last_updated_30] • [promoted]