Quality & Compliance Audit Senior Analyst

7600-Johnson& Johnson do Brasil Industria e Comercio de Produtos para Saude Ltda Legal Entity; São José dos Campos; On-site; BRL 180,000 - 240,000; Full time

Job summary

Johnson & Johnson Brazil seeks a Senior Regulatory Compliance Analyst to support the establishment, control, and maintenance of compliance procedures across the site, aligning with ISO, GMP, and QSR requirements.

You will coordinate external inspections, audits, and internal audit programs, partnering with cross-functional teams to drive continuous improvement and ensure regulatory readiness.

Qualifications

• Bachelor’s degree in Business Administration or related field.
• Minimum of 6 years in medical device/pharma or regulated environment.
• Advanced English proficiency.

Responsibilities

• Support external inspections and audits readiness (FDA, Notified Body, corporate audits).
• Coordinate audit execution logistics and SME preparation.
• Support Internal Audit Program scheduling, auditor qualification, and metrics.
• Investigate findings from audits and ensure corrective actions.
• Monitor quality/compliance metrics and escalate risks as needed.
• Assist in quality system improvements and regulatory requirements alignment.

Skills

Agile Internal Audit

Analytical Reasoning

Audit Reporting

Compliance Management

Quality Standards

Regulatory Environment

Critical Thinking

Detail-Oriented

Problem Solving

Education

Bachelor’s degree in Business Administration

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.

Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.

Job Function

Quality

Job Sub Function

Quality & Compliance Audit

Job Category

Professional

Job Posting Locations

São José dos Campos, São Paulo, Brazil

Job Description

Senior Regulatory Compliance Analyst Position Summary The Senior Regulatory Compliance Analyst is responsible for supporting the establishment, control, and maintenance of compliance procedures and processes to ensure adherence to regulatory requirements and company compliance standards. The role supports and coordinates key Regulatory Compliance activities, working with moderate supervision and partnering with cross-functional teams across the site.

Key Responsibilities

• Support and coordinate external inspection and audit readiness activities, including preparation for regulatory inspections, Notified Body audits, FDA inspections, and corporate audits.
• Coordinate audit execution and support activities, including logistics, Front Room/Back Room support, SME preparation, communications, and responses to observations.
• Support the execution of the Internal Audit Program, including audit scheduling and execution, auditor qualification, and monitoring and improvement of audit metrics.
• Support investigations resulting from internal and external audits, including follow-up, effectiveness monitoring, and closure.
• Monitor and report Quality and Compliance metrics, identify adverse trends, support risk-based actions, and escalation compliance issues as appropriate.
• Support the implementation and continuous improvement of the Quality System, compliance standards, and new or revised regulatory requirements.
• Partner with Compliance teams and cross-functional stakeholders to strengthen compliance across the site.
• Provide Compliance education and training related to QSR, ISO, and GMP requirements, as needed.
• Support site Health, Safety, Environmental, and Compliance requirements and perform other responsibilities as assigned.

Qualifications & Experience

• Bachelor’s degree in Business Administration, Pharmacy, Biology, Engineering, Chemistry, or a related field.
• Training in Quality Auditing, ISO standards, and regulatory requirements.
• Minimum of 6 years of experience in the medical device or pharmaceutical industry, or equivalent experience in another regulated environment.
• Advanced English proficiency.

Skills

• Strong communication skills and ability to build credibility with different stakeholders.
• Ability to work effectively in complex and dynamic environments.
• Ability to make complex information clear and easy to understand.
• Technical understanding of products and processes, combined with business and compliance knowledge.
• Ability to support change and build strong internal and external partnerships.
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.

Required Skills

• Agile Internal Audit
• Analytical Reasoning
• Audit and Compliance Trends
• Audit Reporting
• Business Behavior
• Compliance Management
• Compliance Policies
• Compliance Risk
• Critical Thinking
• Detail-Oriented
• Problem Solving
• Quality Control (QC)
• Quality Standards
• Regulatory Environment

Additional Company Overview

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 https://www.jnj.com/.