Audit Manager

Audit Manager

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:

SENIOR MANAGER RD QC GMP AUDITING

Location:

North America, United States, New Jersey, Summit

勤務地:

完全リモート

あなたがすること

This role is responsible for comprehensive audits of suppliers and service providers to assess compliance with GMPs, regulatory standards and Kenvue policies and procedures. The audit manager will conduct audits of multiple regulatory classifications (OTC Drug Products, Cosmetic Products, Food and Nutritional Products, Class I or II Medical Devices, and Combination Products) and may include Excipients, Food/Nutritional Ingredients, Chemicals, Packaging Components, Fiber/Non-Wovens, Laboratories (analytical and/or microbial), warehouses, 3PL and other service providers. 

The Audit Manager is responsible for organizing, conducting, reporting and working with other quality professionals on responses and CAPAs for supplier audits. The Audit Manager will collaborate with suppliers and Kenvue business partners to develop CAPA plans and remediations as needed. They will review and approve audit reports and audit documentation for other auditors on the team.  They will also work with Supplier Quality to support supplier reliability initiatives in Supplier Quality.

The scope of audits is suppliers across North America, primarily US and Canada.

Key Responsibilities

• Carry out job duties independently
• Perform audits (Onsite, Remote Desktop, Quality Questionnaire and/or Internal Assessments/Performance Evaluations) of suppliers / service providers (Excipients, Food/Nutritional Ingredients, Chemicals, Packaging Components, Fiber/Non-Wovens, Laboratories (analytical, stability and/or microbial), warehouses, 3PL and other service providers). 
• Review systems, documentation, records, and procedures related to manufacturing, packaging, warehousing, testing and/or service provided to verify compliance to GMPs and applicable regulations
• Identify observations, deviations and areas for improvement during audit and work with stakeholders to develop CAPA and remediation plans.
• Prepare written audit reports and documents in accordance with Kenvue procedures and requirements; ensuring the quality and accuracy of all audit documentation; ensure timeliness for assigned audits are met
• Collaborate with stakeholders to develop corrective action plans and review objective evidence of the corrections
• Perform Management Notification of audit results as needed
• Manage the relationship with qualified third-party audit providers as necessary

Required Qualifications

• University/Bachelors Degree in a technical field (Engineering, Sciences, or similar disciplines) required.  Masters or an advanced degree is preferred.
• A minimum of 10 years of experience of GMP experience in either Pharmaceutical, Medical Device Manufacturing, OTC Drug, Cosmetic, and/or Food and Dietary Supplements production. Experience in a Quality Assurance function is required.
• A minimum of 5 years of experience conducting audits for at least 3 of the following types of suppliers:
• API Manufacturers
• Pharmaceutical or OTC Drug, Medical Device, Food/Dietary Supplement, or Cosmetic Finished Goods manufacturers
• Food and Nutritional Ingredients
• Excipient / Chemical Manufacturers
• Packaging Components Manufacturers
• Laboratories (Analytical and Microbial)
• Repacking / Relabeling Facilities
• Warehousing and Distribution
• In depth knowledge of GMP regulations and international regulations/guidelines (ICH, IPEC etc.).  FDA and Health Canada regulations and enforcement trends.
• Strong understanding of manufacturing, processes, validation, material handling, cleaning and risk assessment requirements.
• Ability to be on your feet for long periods of time, walking and climbing steps
• Excellent communication and interpersonal abilities
• Strong analytical and problem-solving skills
• Attention to detail.

Desired Qualifications

• Located in the Midwest US, Northeast US or Ontario, Canada
• In close proximity to an international airport / airline hub city
• Ability to successfully utilize Data Management tools and software to manipulate data is required (for example, Excel, Trackwise, Tableau, ETQ, or related software).

それは何ですか

$124,100.00 - $175,200.00

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.

Kenvueは機会均等雇用者であることを誇りに思っています。人種、肌の色、宗教、性別、性的指向、性同一性、年齢、出身国、または保護された退役軍人の地位に関係なく、すべての資格のある応募者は、能力に基づいて雇用の検討を受け、障害に基づいて差別されることはありません。