Senior Compliance Auditor

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

Location:

Work Location:

What you will do

This position reports to the Compliance Manager and is an on-site role based in Las Piedras, Puerto Rico.

The Senior Compliance Auditor is responsible for ensuring Quality Systems, non-compliance investigations, and audit activities are conducted in accordance with current Good Manufacturing Practices (cGMPs), company procedures, FDA regulations, and applicable international standards. The role serves as a key compliance subject matter expert, leading internal audit activities, supporting regulatory inspections, driving continuous improvement initiatives, and ensuring the effectiveness of site quality metrics programs. 

Key Responsibilities

• Lead and support internal audits, including serving as Lead Auditor when assigned.
• Conduct investigations related to Quality Systems and non-compliance events, ensuring timely resolution and appropriate corrective and preventive actions.
• Support regulatory inspections, supplier audits, and third-party assessments, ensuring inspection readiness and compliance with applicable regulations.
• Present audit findings, evaluate responses, and track commitments through completion and documentation.
• Monitor quality trends, identify compliance risks, and recommend process improvements to enhance Quality Systems performance.
• Develop, revise, and maintain procedures and quality documentation to ensure ongoing regulatory compliance.
• Participate in the development and implementation of remediation plans resulting from audits, inspections, investigations, and quality events.
• Support cGMP training programs and promote a culture of quality and compliance across the organization. 

Quality Metrics & Analytics:

• Coordinate the Site Quality Metrics Program through data collection, analysis, trending, and reporting activities.
• Partner with process owners to ensure timely and accurate quality metrics submissions and evaluations.
• Prepare management review presentations and provide insights to support quality and compliance decision-making.
• Monitor key quality indicators and ensure follow-up actions resulting from management reviews are completed. 

Cross-Functional Partnership:

• Collaborate with Quality, Manufacturing, Regulatory Affairs, and other functional teams to drive compliance and continuous improvement initiatives.
• Partner with internal stakeholders to harmonize processes, improve operational effectiveness, and strengthen overall compliance performance.
• Interact with suppliers, consultants, and regulatory authorities as required. 

What We Are Looking For

Required Qualifications:

• A minimum of a Bachelor's degree in Natural Sciences.
• A minimum of six years of experience in Quality Compliance and/or Regulatory Compliance within an FDA-regulated industry.
• Experience in pharmaceutical and/or OTC manufacturing environments.
• A minimum of two years of GMP auditing experience.
• Experience working with controlled substances/products and knowledge of DEA regulations.
• Experience supporting regulatory inspections, investigations, internal and external audits, and Quality Systems activities.
• Experience with quality metrics collection, analysis, trending, and reporting.
• Strong knowledge of cGMP regulations, including 21 CFR Parts 11, 210, and 211.
• Knowledge of international regulatory requirements, including Europe, Canada, and China.
• Strong analytical, technical writing, presentation, and project management skills.
• Ability to influence stakeholders, lead cross-functional discussions, and work independently on complex compliance matters.
• Bilingual proficiency in English and Spanish.
• Proficiency in Microsoft Office applications. 

Preferred Qualifications:

• GMP Auditor Certification from a recognized pharmaceutical organization.
• Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) certification.
• Experience supporting supplier audits and regulatory inspections.
• Experience leading quality improvement and compliance initiatives within regulated manufacturing environments.

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What’s in it for you

This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.