Onsite Senior Compliance Auditor - GMP & Regulatory Expert

Kenvue; Las Piedras (PR); On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

Competitive Benefit Package

Paid Company Holidays, Paid Vacation,

Learning & Development Opportunities

Kenvuer Impact Networks

Job summary

Kenvue in Las Piedras, Puerto Rico, is seeking a Senior Compliance Auditor to lead internal audits, investigations, and regulatory readiness, ensuring cGMP compliance across Quality Systems.

You will collaborate with Quality, Manufacturing, Regulatory Affairs and other teams, oversee metrics, and drive improvements. A Bachelor’s in Natural Sciences and 6+ years in FDA-regulated compliance, with GMP auditing and DEA knowledge, are required.

Qualifications

• Bachelor's degree in Natural Sciences required.
• Six years of experience in Quality/Regulatory Compliance in an FDA-regulated industry.
• Experience in pharmaceutical and/or OTC manufacturing environments.
• GMP auditing experience (at least 2 years).
• Experience with DEA regulations and controlled substances.
• Experience supporting regulatory inspections, audits, and Quality Systems activities.
• Experience with quality metrics collection, analysis, and reporting.
• Strong knowledge of cGMP regulations (21 CFR Parts 11, 210, 211).
• Bilingual English/Spanish proficiency.

Responsibilities

• Lead and support internal audits, including Lead Auditor assignments.
• Conduct investigations related to Quality Systems and non-compliance events with timely resolution and CAPA.
• Support regulatory inspections, supplier audits, and third-party assessments.
• Present audit findings and track commitments through completion.
• Monitor quality trends, identify compliance risks, and recommend process improvements.
• Develop, revise, and maintain procedures and quality documentation for regulatory compliance.
• Participate in remediation plans from audits, inspections, investigations, and quality events.
• Support cGMP training programs and promote a culture of quality and compliance.
• Coordinate the Site Quality Metrics Program with data collection, analysis, trending, and reporting.
• Prepare management review presentations and provide insights for decision-making.
• Interact with stakeholders to harmonize processes and strengthen compliance.

Skills

Quality Compliance

Regulatory Compliance

GMP auditing

Analytical skills

Technical writing

Presentation skills

Project management

Bilingual English/Spanish

Education

Bachelor's degree in Natural Sciences

Tools

Microsoft Office

Job description

Kenvue in Las Piedras, Puerto Rico, is seeking a Senior Compliance Auditor to lead internal audits, investigations, and regulatory readiness, ensuring cGMP compliance across Quality Systems.

You will collaborate with Quality, Manufacturing, Regulatory Affairs and other teams, oversee metrics, and drive improvements. A Bachelor’s in Natural Sciences and 6+ years in FDA-regulated compliance, with GMP auditing and DEA knowledge, are required.