Commercial Quality Analyst EP (fixed-term 12 months)

Johnson & Johnson Innovative Medicine; São Paulo; Presencial; BRL 120 000 - 180 000; Tempo integral

Resumo da oferta

Johnson & Johnson Innovative Medicine in São Paulo, Brazil seeks a Quality Systems Specialist to support the QMS across the region. You will ensure compliance with quality policies, standards, SOPs, regulatory requirements and industry standards, while contributing to governance and performance metrics.

Responsibilities include training coordination, audits support, CAPA investigations and collaboration with Regulatory, Medical Affairs, Supply Chain and other partners to drive continuous

Qualificações

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Business Administration or related field.
• Minimum 2 years of experience in Quality, Compliance, Regulatory Affairs, Quality Systems or related areas.
• Experience with Quality Management Systems and regulated environments preferred.
• Proficient in Microsoft Office and data visualization tools.
• Trilingual: English, Spanish and Portuguese.

Responsabilidades

• Support the execution and maintenance of Quality Management System processes across the region, ensuring compliance with internal and external requirements.
• Support Quality Systems governance activities, including document control, change management, training compliance, CAPA follow-up and risk management processes.
• Monitor Quality Management System performance through quality metrics, KPIs, dashboards and Power BI reports, identifying trends and opportunities for improvement.
• Support preparation and reporting of Quality Management System Review (QSMR) activities, including collection, analysis and presentation of quality metrics.
• Coordinate and support regional Quality Systems training activities, promoting awareness and compliance with applicable quality requirements.
• Support internal and external audits, inspections and assessments related to the Quality Management System, including preparation of documentation, evidence gathering and follow-up of actions.
• Participate in investigations related to nonconformances, CAPAs, audit observations and quality system issues, supporting root cause analysis and effectiveness verification.
• Collaborate with Commercial Quality, Customer Operations, Regulatory Affairs, Medical Affairs, Supply Chain, Service Solutions and other business partners to ensure effective execution of QMS processes.
• Support implementation of new Quality System requirements resulting from regulatory changes, global initiatives or business transformation projects.
• Lead and support continuous improvement initiatives focused on enhancing compliance, process effectiveness and operational excellence.
• Support the maintenance and revision of Quality System documentation, including procedures, work instructions, training curricula and controlled documents.
• Support regional and global projects related to Quality Systems, Digital Quality and Process Excellence initiatives.

Conhecimentos

English

Spanish

Portuguese

Analytical mindset

Strong communication

Stakeholder management

Formação académica

Bachelor's degree in Engineering, Life Sciences, Pharmacy, Business Administration or related field

Ferramentas

Power BI

Excel

PowerPoint

Word

Descrição da oferta de emprego

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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Job Sub Function

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São Paulo, Brazil

Job Description

Overall Purpose of Job

• Support the implementation, maintenance and continuous improvement of the MedTech Quality Management System (QMS) in EP Brazil/Southern Cluster, ensuring compliance with applicable Johnson & Johnson Quality Policies, Quality Standards, Standard Operating Procedures, regulatory requirements and industry standards.
• Responsible for supporting QMS governance activities, performance monitoring, quality metrics development and reporting, contributing to the effectiveness and sustainability of the Commercial Quality Management System.

Essential Duties And Responsibilities

• Support the execution and maintenance of Quality Management System processes across the region, ensuring compliance with applicable internal and external requirements.
• Support Quality Systems governance activities, including document control, change management, training compliance, CAPA follow-up and risk management processes, as applicable.
• Monitor Quality Management System performance through quality metrics, KPIs, dashboards and Power BI reports, identifying trends and opportunities for improvement.
• Support preparation and reporting of Quality Management System Review (QSMR) activities, including collection, analysis and presentation of quality metrics.
• Coordinate and support regional Quality Systems training activities, promoting awareness and compliance with applicable quality requirements.
• Support internal and external audits, inspections and assessments related to the Quality Management System, including preparation of documentation, evidence gathering and follow-up of actions.
• Participate in investigations related to nonconformances, CAPAs, audit observations and quality system issues, supporting root cause analysis and effectiveness verification.
• Collaborate with Commercial Quality, Customer Operations, Regulatory Affairs, Medical Affairs, Supply Chain, Service Solutions and other business partners to ensure effective execution of QMS processes.
• Support implementation of new Quality System requirements resulting from regulatory changes, global initiatives or business transformation projects.
Lead and support continuous improvement initiatives focused on enhancing compliance, process effectiveness and operational excellence.
• Support the maintenance and revision of Quality System documentation, including procedures, work instructions, training curricula and controlled documents.
• Support regional and global projects related to Quality Systems, Digital Quality and Process Excellence initiatives.

Job Requirements

Essential Knowledge and Skills

Education

• Bachelor’s Degree in Engineering, Life Sciences, Pharmacy, Business Administration or related field.

Experience

• Minimum 2 years of experience in Quality, Compliance, Regulatory Affairs, Quality Systems or related areas.
• Experience working with Quality Management Systems and regulated environments is preferred.
• Proficiency in Microsoft Office applications (Excel, PowerPoint, Word) and data visualization tools.

Other

• Trilingual: English, Spanish and Portuguese.
• Power BI knowledge preferred.
• Knowledge of quality standards and regulations applicable to medical devices is desirable.

Core Competencies Required For This Role

• Analytical Mindset
• Strong Communication Skills
• Strong Analytical and Problem-Solving Skills
• Organizational Skills
• Strong Interpersonal Skills
• Continuous Improvement Orientation
• Stakeholder Management
• Learning Agility
• Compliance and Quality Mindset
• Ability to Work in Cross-Functional and Regional Environments

Preferred Skills

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing