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We are searching for the best talent for Manager, Quality Systems LATAM to be in Panama, Sao Paulo, Sao Jose dos Campos, Purpose: The Regional Quality System Sr Supervisor - QMS Core, this position is responsible of definition of the Quality Management System strategy and execution across the region (and at regional functional areas level as well) considering global, regional and local needs and trends.
Establishing and leading Johnson & Johnson overall quality management framework implementation and the management of the quality system for the Region, establishing preventive and corrective actions to mitigate potential or actual non-compliance risks and ensuring compliance to attain world-class operational/customer focused capabilities in the Storage, Distribution & Commercial operations in Latin America for the MedTech Sector, including external partnership.
The Regional QMS Manager has accountability and responsibility for the implementation of regional regulatory compliance to J&J Global Standard, Cross and Segment specific SOPs that impact the Regional Quality System acting as a liaison between Global CQ team and Latam Clusters CQ, ensuring the deployment of Quality Standards, QMS processes and initiatives and Global projects.
Responsible for the Governance of QMS related Metrics in the region.
The overall management responsibilities also require expert leadership in regional projects and initiatives providing strategic direction to achieve established goals.
Role complexity includes but is not limited to ability to interact cross segment and representation of the region in global projects and initiatives You will be responsible for : Leadership Role; • Develop and support direct reports.
• Act and foster others to work based on Our Credo.
Manage Quality Systems • Ensure Quality strategic direction and alignment for process execution.
• Provides Quality Assurance, Compliance and Management Oversight and Leadership in the implementation and maintenance of the Regional Quality System.
• Oversees the implementation and management of Commercial Quality Manual and Regional Standard Operating Procedures, ensuring simplicity, standardization, and education across the countries.
• Maintain the Quality Manual updated.
• Ensure compliance to J&J Policy, Quality Standards, and regulatory requirements.
• Supports the implementation of applicable requirements to the regional Quality System, such as requirements from the MT Segment, Cross-Segment and global, regional or local requirements.
• Ensures that the processes established by the Quality System have the necessary structure for its execution.
• Ensures that processes managed in a regional level are in place, such as document control, records management, change controls, personnel training and qualification, customer services, product complaint handling, quality issue management (NC/CA/PA), quality system management review and internal audit.
• Manage corrective and preventive actions, change management actions and risk management processes, when applicable.
• Ensure the Implementation, maintain and deploy the E2E process for QMS related metrics in the region.
• Prepare the metrics from the region to present in the Staff and Global meetings.
• Lead quality metrics and data analytics strategy.
• Stablish the QMS Governance Model within CQ LATAM • Serves as a catalyst to ensure the compliance with the applicable J&J policies, quality requirements, local regulations.
• Supports the internal or external audits and inspections that verifies the regional QMS.
• Supports LATAM countries and MedTech regional functional areas in the execution of the Quality System processes.
• Develop appropriate strategic and process performance measures/targets.
• Establish and maintain global and local relationships with partnering organizations and regulatory bodies.
• Operate as a key business partner for quality and process improvement, understand business requirements.
• Understand current requirements of Regulatory Agencies such as local MOH's, as well as, of standard organizations such as ISO.
Strategy and Planning • Develop a common vision and strategy for Quality and Process Improvement.
• Entrench a process improvement culture within the business, operational and supporting functional areas.
Enhance process management practices.
• Develop appropriate strategic and process performance measures/targets.
Relationship Management • Represent the region in Global and Regional forums, leading functional efforts as required to achieve results.
• Partner with the Clusters, Regional and Functional Community, Business Leaders and Functional areas.
• Work with business partners to build capability and ensure compliance to regulations and quality standards.
Strengthen quality & compliance capability in the organization, through tools like trainings, communities of practices, new sletters, conferences, and related initiativesQualifications: Education: - Bachelors or Master's degree in Business, Pharmacy/Chemistry/Biosciences, Engineering or equivalent field, or health-related discipline - Bilingual (English-Spanish).
Good PC's skills.
Supply Chain knowledge Experience: Minimum 6 years of relevant quality leadership role of which a minimum of 3 years in pharmaceutical, medical device, or healthcare industry.
• Fluent in English • Advanced in Spanish/ Portuguese • Good skills in working under matrix structure (cross-function, cross-segment) • Ability to work well with senior management personnel in an effective manner to communicate Quality and Compliance to them.
• Ability to make decisions about scheduling, allocation of resources and leading priorities.