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    Senior Manager Commercial Quality - Chile - Johnson & Johnson

    Johnson & Johnson
    Johnson & Johnson Chile

    hace 1 semana

    Johnson & Johnson background
    Descripción

    Diversity, Equity & Inclusion are essential to continue building ourhistory of pioneering and innovation, which has been impacting thehealth of more than 1 billion patients and consumers every day formore than 130 years.

    Regardless of your race, belief, sexualorientation, religion, or any other trait, YOU are welcome in all openpositions at the largest healthcare company in the world.

    WhenYou Join Johnson & Johnson, Your Move Could Mean Our NextBreakthrough.

    At Johnson & Johnson MedTech, we unleash diversehealthcare expertise, purposeful technology, and a passion for peopleto transform the future of medical intervention and empower everyoneto live their best life possible.

    For more than a century, we havedriven breakthrough scientific innovation to address unmet needs andreimagine health.

    In surgery, orthopedics, vision, and interventionalsolutions, we continue to help save lives and create a future wherehealthcare solutions are smarter, less invasive, and morepersonalized.


    We are searching for the best talent for SENIORMANAGER COMMERCIAL QUALITY to be in Santiago,Chile.

    *Purpose**:

    Under the general direction of theCommercial Quality Senior Director, this position is responsible forestablishing and leading Johnson & Johnson overall quality managementframework and quality system for the cluster, establishing preventiveand corrective actions to mitigate potential or actual non-compliancerisks and ensuring compliance to attain world-classoperational/customer focused capabilities.

    The overall managementresponsibilities also require exerting leadership in regional projectsand initiatives providing strategic direction to achieve establishedgoals.

    Role complexity includes but is not limited to ability tointeract cross segment and representation of the region in globalprojects and initiatives.

    The Senior Quality Manager is responsible tolead activities towards the integration of the quality managementsystems for applicable country(ies).

    This position is responsible forensuring the QMS requirements are effectively executed in the marketsin accordance with local regulations, corporate and segment policiesand procedures.

    The scope of this role is applicable to the CommercialQuality operations in the cluster (Brazil, Mexico,

    Northern Clusteror Southern Cluster
    You will be responsible for: -Lead the Cluster Commercial Quality organization, including handling,storage, distribution and commercial activities, to ensure a proactiveapproach to quality assurance and quality systems.


    • Developappropriate strategic and process performance measures/targets.
    • Manage the overall corrective and preventive action (CAPA) and riskmanagement processes.
    • Establish and maintain global and localrelationships with partnering organizations and regulatorybodies.
    • Oversee the management of Standard Operating Procedures,ensuring simplicity, standardization and education across thecountries.
    • Operate as a key business partner for quality andprocess improvement, understand business requirements.
    • Ensurecompliance to all applicable quality standards and regulatoryrequirements
    • Ensure troubleshooting and solutions to qualityissues through statistical analysis and process excellence tools.
    • Present case studies and metrics to Cluster Leadership.
    • Coordinate execution of internal audit, and 2nd party audit asneeded.
    • Lead the management review process for the cluster asManagement Representative. Propose initiatives for quality performanceimprovement.
    • Drive complaint vigilance execution in the countriesensuring the timely closure of product related complaints cases,quality, and immediate escalation.
    • Understand currentrequirements of Regulatory Agencies such as local MOH's, as well as,of standard organizations such as ISO.
    • Ensure compliance with theJ&J policies and local regulations at the local warehouses anddistributors, including external partners. Liaising with otherfunctional areas as appropriate in the execution of these tasks.
    • Partner with Deliver Operations to establish proper surveillance ofthe distribution activities (cold chain and loaner kits)
    • Effectively work with Cross Segment leadership (functional andcommercial) in the deployment and
    sustainability of initiativesthat will support QMS execution and compliance on designatedcountries.

    • Management of Pharmacovigilance and Post MarketSurveillance (Technovigilance) systems within the cluster. Strategyand Planning
    • Develop a common vision and strategy for Quality andProcess Improvement
    • Entrench a process improvement culture withinthe business. Implement process management practices, verify/validateproject results and advocate further use of PE to drive businessresults.
    • Embed QMS management principles in the organization,creating crossfunctional process improvement teams who effectivelycomplete improvement projects central to these efforts.
    • Engageall company employees in these i #J18808Ljbffr
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