LATAM Transportation Quality Manager
PharmaMedTechRegulatory AffairsQuality Assurancegmpfdaiso 13485cro
Job description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Quality Assurance Job Category: People Leader All Job Posting Locations: São José dos Campos, São Paulo, Brazil, São Paulo, Brazil Job Description: Overall purpose of job: The Transportation and Temperature Control Quality Manager provides regional Quality and Compliance leadership for transportation and distribution operations, with accountability for temperature control, Quality Management System execution, supplier quality performance, quality metrics, audit readiness, and shared services governance. The role partners with Commercial Quality, Transportation, Supply Chain, Enterprise Quality, Regulatory, suppliers, and logistics service providers to identify compliance risks, resolve quality issues, improve operational performance, and support strategic business initiatives in accordance with applicable health authority regulations and J&J Quality Standards. Key responsibilities: Quality Strategy, Governance & Shared Services Leadership Lead regional Commercial Quality Shared Services strategy for transportation quality, quality management systems, supplier quality, training, metrics, and compliance programs. Define, harmonize, implement, and continuously improve regional Q&C processes, systems, standards, and procedures in alignment with J&J policies, J&J Quality Standards, and applicable regulations. Establish and monitor regional quality objectives, scorecards, business review inputs, management review content, and performance indicators to drive compliance, effectiveness, and business value. Provide senior Quality leadership, coaching, direction, and talent development for assigned direct and matrixed resources. Transportation & Temperature Control Quality Oversight Serve as the regional Quality point of contact and subject matter expert for transportation, distribution, and associated temperature control activities. Oversee transportation lane mapping, route verification, mode qualification, transport qualification, controlled ambient, cold chain, and temperature monitoring requirements. Ensure appropriate investigation, product impact assessment, remediation, communication, and trending of transportation temperature excursions, humidity excursions, customer complaints, and transportation-related quality issues. Provide Quality oversight for transportation network changes, new product introductions, transportation procurement activities, and carrier/service provider performance. Quality Management System Ownership & Compliance Execution Oversee and support QMS processes including training, document management, change control, CAPA, nonconformance, internal audit, validation, quality metrics, and regulated quality system tools. Ensure QMS requirements are built into transportation and temperature control projects, process changes, supplier activities, audits, and improvement initiatives. Coordinate documentation, approval workflows, training deployment, effectiveness checks, system access requirements, periodic reviews, and QMS reporting as applicable. Monitor compliance trends, identify gaps, escalate risks, and implement corrective and preventive actions to maintain inspection readiness. Supplier Quality & Logistics Service Provider Management Lead or support supplier quality oversight for transportation carriers, logistics service providers, freight forwarders, and other transportation partners within scope. Evaluate supplier and carrier quality performance through metrics, audits, business reviews, complaints, excursions, CAPA trends, and continuous improvement programs. Partner with Supplier Quality, Procurement, Transportation, Commercial Quality, and Enterprise Quality organizations to align supplier oversight and purchasing control expectations. Audit, Inspection & Regulatory Readiness Support and/or lead preparation, execution, and follow-up for Health Authority inspections, JJRC audits, third-party audits, internal audits, supplier audits, and compliance reviews related to transportation, QMS, distribution, and shared services scope. Assess transportation and quality process capabilities against company standards, industry expectations, applicable regulations, and emerging regulatory requirements. Ensure timely response, remediation, escalation, and follow-through for audit observations, quality issues, CAPAs, and inspection commitments. Metrics, Reporting, Business Reviews & Continuous Improvement Deliver timely, accurate, and meaningful quality metrics and reports for regional transportation quality, shared services, QMS, supplier quality, training, quality events, audits, and continuous improvement programs. Use metrics, scorecards, trend analysis, and business review forums to identify compliance risks, performance gaps, process inefficiencies, and improvement opportunities. Lead or support regional and global projects that improve cost, quality, compliance, cycle time, digital tools, reporting, and service performance. Budget, Benchmarking & External Engagement Support budget planning, resource planning, project prioritization, and monitoring for assigned quality programs and shared services initiatives. Participate in benchmarking, industry forums, regulatory engagement, and cross-regional knowledge sharing to strengthen program strategy and compliance maturity. Other Duties Perform other Quality, Compliance, Shared Services, Transportation, Supplier Quality, or QMS responsibilities as assigned and aligned with business needs. Escalate qua
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