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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 quality, compliance, safety, delivery, or business risks through appropriate quality and management channels. 

 

Required Qualification and Core Competencies for the role:

Required Minimum Education: Bachelor’s degree required in engineering, science, pharmacy, business, quality regulatory compliance, supply chain, or related discipline. Master’s degree in engineering, science, or business preferred. 

Required Years of Related Experience: Minimum 8 years of related experience in a regulated healthcare industry, preferably medical devices, pharmaceutical, distribution, transportation, temperature control, package development, supplier quality, QMS, regulatory compliance, or commercial quality operations. 

 

Required Knowledge, Skills and Abilities:  

. Advanced oral and written English is required. Spanish highly preferred.

·       Knowledge of applicable quality systems, healthcare regulations, Good Distribution Practices, ISO 9001, ISO 13485, FDA requirements, J&J Quality Standards, supplier quality, CAPA, NC, investigations, audits, change control, validation, training, document management, and QMS processes. 

·       Experience with transportation quality oversight, route verification, lane mapping, mode qualification, cold chain, controlled ambient transportation, temperature monitoring, and excursion management. 

·       Ability to assess multiple issues, interpret compliance and business impact, and translate risks into practical system, process, supplier, and operational requirements. 

·       Demonstrated ability to lead people and cross-functional teams, influence without direct authority, build consensus, coach talent, manage performance, resolve conflict, and drive change across matrixed regional organizations. 

·       Strong project management, metrics reporting, continuous improvement, business review, and presentation skills. Ability to make complex quality and compliance topics clear and actionable. 

·       Expert-level technical knowledge in Quality Management Systems, transportation quality, temperature control, supplier quality, and regulated healthcare distribution operations. 

·       Strong leadership, collaboration, influence management, communication, presentation, analytical, strategic, decision-making, and problem-solving skills. 

·       Understanding of quality and regulatory compliance linkages from product development through manufacturing, transportation, distribution, delivery to customer, and health authority expectations. 

·       Previous experience interfacing with regulatory agencies, notified bodies, internal audit teams, supplier partners, and logistics service providers is preferred. 

 

 

 

Required Skills:

 

 

Preferred Skills:

Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management