Senior Compliance Auditor

Kenvue Inc.

Las Piedras (PR)

On-site

USD 74,000 - 104,000

Full time

10 days ago

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Benefits offered by this job

Competitive compensation and benefits

Company holidays and paid time off

Learning & development opportunities

Job summary

Kenvue Inc.は、プラセボ薬を含む医薬関連製品の品質システムと法令遵守を確保するSenior Compliance Auditorを募集します。ローカルはラスピエドラス（プエルトリコ）で、現場勤務のオンサイトポジションです。監査計画の策定・実施、調査対応、規制検査のサポートを通じて、cGMP基準とFDA規制の遵守を推進します。

責任には監査手続の指揮、是正処置の追跡、品質指標の分析、部門間の協力、監査報告の作成が含まれます。英語とスペイン語のバイリンガル能力が望まれ、強い分析力とプレゼン能力が求められます。

Qualifications

FDA規制業界でのQuality/Regulatory compliance経験が6年以上必要。
GMP監査経験は最低2年以上。
有害薬物/DEA規制の経験が望ましい。
規制検査対応、内部外部監査、Quality Systems活動の経験。
品質指標の収集・分析・報告の経験。
cGMP規制（21 CFR Parts 11, 210, 211）の知識。
英語とスペイン語のバイリンガル能力。
Microsoft Officeの熟練。

Responsibilities

内部監査を主導・サポートし、場合によりLead Auditorを務める。
Quality Systemsの違反事象調査と是正・予防処置を実施。
規制検査・サプライヤー監査・第三者評価の準備・対応。
監査所見を提示し、回答を評価・約束事項を完了まで追跡。
品質トレンドを監視し、リスクと改善を推進。
手続き・品質文書を改訂・維持し法令遵守を確保。
監査・検査・品質イベントからの是正計画の実施。
教育プログラムをサポートし全社的な品質文化を促進。

Skills

GMP auditing

Regulatory compliance

Quality metrics analysis

English/Spanish bilingual

Microsoft Office

Stakeholder influence

Education

Bachelor's degree in Natural Sciences

Tools

Microsoft Office

Job description

Kenvueは現在、a:

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

このポジションの新入社員の年間基本給の範囲:

$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.