Senior Compliance Auditor

Senior Compliance Auditor

Lo que hacemos

En Kenvue, nos damos cuenta del extraordinario poder del cuidado diario. Sobre la base de más de un siglo de herencia y arraigados en la ciencia, somos el hogar de marcas icónicas, incluidas NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® y BAND-AID® que ya conoces y amas. La ciencia es nuestra pasión; El cuidado es nuestro talento.

Quiénes somos

Nuestro equipo global está formado por ~ 22.000 personas brillantes con una cultura laboral en la que cada voz importa y cada contribución es apreciada. Nos apasionan las ideas, innovación y comprometidos con la entrega de los mejores productos a nuestros clientes. Con experiencia y empatía, ser un Kenvuer significa tener el poder de impactar a millones de personas todos los días. Ponemos a las personas en primer lugar, nos preocupamos ferozmente, nos ganamos la confianza de la ciencia y resolvemos con coraje, ¡y tenemos oportunidades brillantes esperándote! Únase a nosotros para dar forma a nuestro futuro y al suyo. Para obtener más información, haga clic en aquí.

Role reports to:

COMPLIANCE MANAGER

Location:

North America, United States, Puerto Rico, Las Piedras

Lugar de trabajo:

Totalmente in situ

What will you

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

$73.950,00 - $104.400,00

Esto tiene en cuenta una serie de factores que incluyen la ubicación del trabajo, las habilidades del candidato, la experiencia, el nivel de educación y otros factores relacionados con el trabajo.

Kenvue se enorgullece de ser un empleador que ofrece igualdad de oportunidades. Todos los solicitantes calificados recibirán consideración para el empleo basada en el mérito sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, edad, origen nacional o estado de veterano protegido y no serán discriminados por motivos de discapacidad.