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Quality Assurance
São José dos Campos, São Paulo, Brazil, São Paulo, Brazil
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.
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 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.
. 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.
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
Apply on Johnson & Johnson (Singapore)’s careers page