Senior Compliance Auditor

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

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Was Sie tun werden

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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Was haben Sie davon

Dies berücksichtigt eine Reihe von Faktoren, darunter den Arbeitsort, die Fähigkeiten des Kandidaten, die Erfahrung, das Bildungsniveau und die andere berufsbezogene Faktoren.

Kenvue ist stolz darauf, ein Arbeitgeber für Chancengleichheit zu sein. Alle qualifizierten Bewerber werden unabhängig von Rasse, Hautfarbe, Religion, Geschlecht, sexueller Orientierung, Geschlechtsidentität, Alter, nationaler Herkunft oder geschütztem Veteranenstatus für eine Beschäftigung in Betracht gezogen und nicht aufgrund von Behinderung diskriminiert.