Audit Manager

Audit Manager

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

SENIOR MANAGER RD QC GMP AUDITING

Posizione:

North America, United States, New Jersey, Summit

Luogo di lavoro:

Completamente remoto

Cosa farai

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).

Cosa c'è per te

$124,100.00 - $175,200.00

Questo tiene conto di una serie di fattori tra cui il luogo di lavoro, le competenze del candidato, l'esperienza, il livello di istruzione e altri fattori legati al lavoro.

Kenvue è orgogliosa di essere un datore di lavoro per le pari opportunità. Tutti i candidati qualificati saranno presi in considerazione per l'impiego in base al merito, indipendentemente da razza, colore, religione, sesso, orientamento sessuale, identità di genere, età, origine nazionale o stato di veterano protetto e non saranno discriminati sulla base della disabilità.