Senior Compliance Auditor

Senior Compliance Auditor

私たちがしていること

Kenvueで、日常のケアの並外れた力を実感します。100年以上にわたる伝統を基盤に、科学に根ざした当ホテルは、ニュートロジーナ®、アヴェーノ®、タイレノール®、リステリン®、ジョンソンズ®、バンドエイド®など、すでにお馴染みのアイコニックなブランドを展開しています。科学は私たちの情熱です。ケアは私たちの才能です.

Who We Are

私たちのグローバルチームは~22,000人の優秀な人々で、すべての声が重要で、すべての貢献が評価される職場文化を持っています。 私たちは洞察に情熱を注いでいます。 革新とお客様に最高の製品を提供することに取り組んでいます。専門知識と共感力を持つKenvuerであることは、毎日何百万人もの人々に影響を与える力を持つことを意味します。私たちは人を第一に考え、熱心に気を配り、科学で信頼を勝ち取り、勇気を持って解決します。そして、素晴らしい機会があなたを待っています!私たちと一緒に、私たちの、そしてあなたの未来を形作りましょう。詳細についてはをクリックしてくださいhere.

Role reports to:

COMPLIANCE MANAGER

Location:

North America, United States, Puerto Rico, Las Piedras

勤務地:

フルオンサイト

あなたがすること

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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それは何ですか

$73.950,00 - $104.400,00

これは、勤務地、候補者のスキル、経験、教育レベルなど、多くの要素を考慮に入れています。その他の仕事関連の要因.

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