Quality & Compliance Audit Senior Analyst

Biopharma Asia; São José dos Campos; On-site; BRL 180,000 - 240,000; Full time

Job summary

Johnson & Johnson in Brazil seeks a Senior Regulatory Compliance Analyst to support establishment, control, and maintenance of compliance procedures. You will collaborate with cross-functional teams to ensure regulatory adherence and strong audit readiness across the site.

The role involves coordinating external inspections, internal audits, and continuous improvement of the Quality System, with a focus on QSR, ISO, and GMP requirements.

Qualifications

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

Responsibilities

• Coordinate external inspection and audit readiness activities (regulatory inspections, Notified Body audits, FDA inspections, corporate audits).
• Coordinate audit execution logistics, SME preparation, communications, and observations responses.
• Support Internal Audit Program scheduling and execution, auditor qualification, and metric improvement.
• Assist investigations from audits, follow-up, effectiveness monitoring, and closure.
• Monitor and report quality and compliance metrics; identify adverse trends and escalate issues.

Skills

Quality Assurance

Regulatory Compliance

Audit Coordination

Cross-functional Collaboration

English Proficiency

Education

Business Administration

Pharmacy

Biology

Job description

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.

Job Function:

Quality

Job Sub Function:

Quality & Compliance Audit

Job Category:

Professional

All 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.

Preferred 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