Senior Compliance Auditor

Senior Compliance Auditor

我们做什么

在 Kenvue，我们意识到日常护理的非凡力量。我们以一个多世纪的传统为基础，植根于科学，是标志性品牌的品牌 - 包括您已经熟悉和喜爱的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科学是我们的热情所在;关心就是我们的才能。

我们是谁

我们的全球团队由 ~ 22,000 名才华横溢的员工组成，他们的职场文化中，每个声音都很重要，每一个贡献都受到赞赏。 我们热衷于洞察， 创新并致力于为我们的客户提供最好的产品。凭借专业知识和同理心，成为 Kenvuer 意味着每天有能力影响数百万人。我们以人为本，热切关怀，以科学赢得信任，以勇气解决——有绝佳的机会等着您！加入我们，塑造我们和您的未来。有关更多信息，请单击 here.

Role reports to：

COMPLIANCE MANAGER

位置：

North America, United States, Puerto Rico, Las Piedras

工作地点：

完全现场

你会做什么

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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对您有什么好处

$73.950,00 - $104.400,00

这考虑了许多因素，包括工作地点、候选人的技能、经验、教育水平和其他与工作相关的因素

Kenvue 很自豪能成为一个机会均等的雇主。所有合格的申请人都将根据业绩获得就业考虑，不分种族、肤色、宗教、性别、性取向、性别认同、年龄、国籍或受保护的退伍军人身份，并且不会因残疾而受到歧视。