Audit Manager

Was wir tun

Bei Kenvue erkennen wir die außergewöhnliche Kraft der täglichen Pflege. Aufbauend auf über einem Jahrhundert Tradition und verwurzelt in der Wissenschaft, sind wir das Haus der ikonischen Marken - darunter NEUTROGENA®, AVEENO®, TYLENOL,® LISTERINE®, JOHNSON'S® und BAND-AID®, die Sie bereits kennen und lieben. Wissenschaft ist unsere Leidenschaft; Fürsorge ist unser Talent.

Wer wir sind

Unser globales Team besteht aus ~ 22.000 brillanten Mitarbeitern mit einer Arbeitsplatzkultur, in der jede Stimme zählt und jeder Beitrag geschätzt wird. Wir sind leidenschaftlich an Erkenntnissen interessiert, Innovation und dem Engagement, unseren Kunden die besten Produkte zu liefern. Mit Fachwissen und Einfühlungsvermögen bedeutet ein Kenvuer zu sein, die Macht zu haben, jeden Tag Millionen von Menschen zu beeinflussen. Wir stellen den Menschen an die erste Stelle, kümmern uns leidenschaftlich, gewinnen Vertrauen in der Wissenschaft und lösen Lösungen mit Mut – und haben brillante Möglichkeiten, die auf Sie warten! Gestalten Sie mit uns unsere Zukunft – und Ihre. Für weitere Informationen, klicken Sie auf hier.

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Was Sie tun werden

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).

Was haben Sie davon

Dies berücksichtigt eine Reihe von Faktoren, darunter den Arbeitsort, die Fähigkeiten des Kandidaten, die Erfahrung, das Bildungsniveau und die andere berufsbezogene Faktoren.

Kenvue ist stolz darauf, ein Arbeitgeber für Chancengleichheit zu sein. Alle qualifizierten Bewerber werden unabhängig von Rasse, Hautfarbe, Religion, Geschlecht, sexueller Orientierung, Geschlechtsidentität, Alter, nationaler Herkunft oder geschütztem Veteranenstatus für eine Beschäftigung in Betracht gezogen und nicht aufgrund von Behinderung diskriminiert.