Audit Manager

Audit Manager

Ce que nous faisons

Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.

Qui nous sommes

Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.

Role relève à :

SENIOR MANAGER RD QC GMP AUDITING

Location :

North America, United States, New Jersey, Summit

Lieu de travail :

Entièrement à distance

Ce que tu vas faire

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).

Qu'est-ce que vous y gagnez

$124,100.00 - $175,200.00

Cela prend en compte un certain nombre de facteurs, notamment le lieu de travail, les compétences du candidat, son expérience, son niveau d'éducation et autres facteurs liés à l'emploi.

Kenvue est fier d'être un employeur souscrivant au principe de l'égalité d'accès à l'emploi. Tous les candidats qualifiés seront pris en considération pour un emploi basé sur le mérite, sans égard à la race, la couleur, la religion, le sexe, l'orientation sexuelle, l'identité de genre, l'âge, l'origine nationale ou le statut d'ancien combattant protégé et ne seront pas discriminés sur la base du handicap.