Audit Manager

Audit Manager

Что мы делаем

At Kenvue, мы осознаем необычайную силу повседневной заботы. Основанный на более чем вековом наследии и уходящий корнями в науку, мы являемся домом культовых брендов, включая NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® и BAND-AID®, которые вы уже знаете и любите. Наука – наша страсть; забота – это наш талант.

Кто мы

Наша глобальная команда – это ~ 22 000 блестящих людей с культурой рабочего места, где каждый голос имеет значение, а каждый вклад ценится. Мы увлечены идеями, инновации и стремление поставлять нашим клиентам лучшие продукты. Обладая опытом и эмпатией, быть Kenvuer означает иметь возможность влиять на миллионы людей каждый день. Мы ставим людей на первое место, заботимся о настолько, завоевываем доверие наукой и смело решаем – и вас ждут блестящие возможности! Присоединяйтесь к нам, чтобы формировать наше будущее и ваше. Для получения дополнительной информации, нажмите here.

Role reports to:

SENIOR MANAGER RD QC GMP AUDITING

Location:

North America, United States, New Jersey, Summit

Место работы:

Полностью удаленный

Что ты будешь делать

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).

Что в этом для тебя

$124,100.00 - $175,200.00

Это учитывает ряд факторов, включая место работы, навыки, опыт кандидата, уровень образования и другие факторы, связанные с работой.

Kenvue гордится тем, что является работодателем равных возможностей. Все квалифицированные кандидаты будут рассматриваться при приеме на работу на основе заслуг независимо от расы, цвета кожи, религии, пола, сексуальной ориентации, гендерной идентичности, возраста, национального происхождения или защищенного статуса ветерана, и не будут дискриминироваться по признаку инвалидности.