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Manager, Quality Engineering Product Surveillance

Repligen Corporation

  • Marlborough, Massachusetts
  • 3 days ago

    Highlights

    This hands-on leader will partner closely with Engineering, Manufacturing, Quality, and Customer-facing teams to address complex quality challenges, drive sustainable improvements, and ensure timely resolution of product-related issues. The ideal candidate brings strong quality systems expertise, a passion for developing people, and the ability to influence across functions while maintaining a strong focus on customer success, team development, and business results.

    Numbers & Facts

    LocationMarlborough, Massachusetts

    Description

    The Manager, Quality Engineering Product Surveillance is a key leadership role responsible for advancing product quality, strengthening customer confidence, and supporting Repligen's ISO 9001 Quality Management System. Reporting to the QA Director, this individual will lead a team focused on quality investigations, continuous improvement, and cross-functional problem solving while fostering a culture of accountability, collaboration, and operational excellence.

    This hands-on leader will partner closely with Engineering, Manufacturing, Quality, and Customer-facing teams to address complex quality challenges, drive sustainable improvements, and ensure timely resolution of product-related issues. The ideal candidate brings strong quality systems expertise, a passion for developing people, and the ability to influence across functions while maintaining a strong focus on customer success, team development, and business results.

    This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.

    Responsibilities:

    • Leadandsupporttheongoingmanagementandmaintenanceoftheelectroniccomplaintmanagementsystem,ensuringdataintegrity,efficiency,andcompliancewithestablishedprocesses.
    • Provideday-to-dayleadershipforcomplainthandlingactivities,establishingpriorities,managingescalations,removingroadblocks,andensuringtimely,high-qualityexecutionacrosstheteam.
    • Leadcomplex,cross-functionalinvestigationsinvolvingQuality,Manufacturing,Engineering,andCustomer-facingteamstoidentifyrootcausesanddriveeffectiveresolutionofproductandservicefailures.
    • Championaproactiveapproachtoproblem-solvingbydrivingcorrectiveandpreventiveactionsthataddressrootcauses,reducerisk,andpreventrecurrence.
    • Buildstrongpartnershipswithcustomersbyparticipatingininvestigationdiscussions,communicatingfindings,andprovidingclear,timelyupdatesoncorrectiveactionsandqualityimprovements.
    • Develop,coach,andempowerteammemberstoconfidentlyexecutecomplainthandlingactivitieswhilestrengtheningtheirunderstandingofqualitysystemrequirements,customerexpectations,andISO9001principles.
    • Driveaccountabilitythroughthemonitoring,analysis,andcommunicationofcomplaintmetricsandkeyperformanceindicators,leveragingtrenddatatoidentifyopportunitiesforcontinuousimprovement.
    • Serveasatrustedliaisonbetweencustomers,Production,Engineering,andQualityteams,fosteringcollaborationandalignmenttoachievethebestpossibleoutcomesforbothcustomersandthebusiness.
    • Supportstrategiccustomerprioritiesandescalationsbybalancingcustomerneeds,businessobjectives,andqualityrequirementswithsoundjudgmentandasenseofurgency.
    • Lead,develop,andretainahigh-performingQualityteamthroughcoaching,feedback,talentdevelopment,andperformancemanagement.
    • Plananddeployqualityresourceseffectivelytomeetbusinessdemandswhilemaintaininghighstandardsforcustomerresponsiveness,compliance,andoperationalexcellence.
    • Demonstratecourageandleadershipinaddressingcomplexqualityissues,makingdata-drivendecisions,anddrivingimprovementsthatstrengthenbothcustomerconfidenceandproductquality.

    Education & Experience

    • Bachelor's degree in Engineering, Life Sciences, or a related field.
    • 7+ years of Quality Assurance and Quality Management Systems experience.
    • Minimum of 3 years of leadership experience.
    • Strong knowledge of ISO 9001 requirements and quality management system principles.
    • Demonstrated expertise in complaint handling, CAPA, root cause analysis, and continuous improvement methodologies.
    • Experience working with electronic quality management systems.
    • Proven ability to lead teams, influence cross-functional partners, and drive results with minimal supervision.
    • Experience leading internal and external quality audits.
    • Strong collaboration and stakeholder management skills across multiple functions and organizational levels.
    • Excellent organizational skills and attention to detail.
    • Proficiency with business and manufacturing software applications, including word processing, presentations, spreadsheets, databases, and internet-based tools.
    • Strong technical writing, communication, and presentation skills.
    • Ability to effectively communicate with both internal and external stakeholders.
    • Salesforce.com experience is a plus.

    Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $110,858-$156,358. Compensation decisions are dependent on several factors including, but not limited to an individual's ,qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.

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