Sr Analyst , Quality Systems

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:

SUP REG QA

Местонахождение:

Latin America, Brazil, Sao Paulo, Sao Jose dos Campos

Место работы:

Гибрид

Что ты будешь делать

Role overview

The Sr Analyst, Quality Systems will be responsible for delivering quality plans across the region in order to achieve Veeva QMS transf project milestones in several workstreams such as Investigation and CAPA, Change Control, Quality Management System Adequacy, change management, documentation updates including milestones completion reporting, deployments plan coordination and others.

Key Responsibilities

• Take accountability on Latam milestones associated to QMS quality project implementation related to Veeva tech Solution in the region.

• Build collaboration across different functional areas with business partners

• Build alignment with Sponsor, aligns Core and Extended team to deliver the Final Project Objectives

• Develop, manage, and maintain up-to-date Latam project plans through collaboration with cross functional team members

• Ensure seamless coordination across all workstreams, fostering cross-functional collaboration to maintain synchronization and meet project deliverables following quality requirements.

• Provide project implementation activities across all workstreams such as: mapping and scenarios testing, risk management in integration activities.

• Management to track all Latam project smartsheet related activities on-time and in compliance with Kenvue procedures and country-specific quality/regulatory requirements for Veeva Implementation.

• Manage risks effectively, identify potential problems early, and assist in resolving or raising issues as appropriate.

• Effectively prepare and communicate project status updates regarding project milestones, deliverables, and risks within the workstreams and for the broader project

• Support the functional teams as part of the implementation team as Point of Contact and act as the SME for the quality systems’ processes in project scope (i.e: INV/CAPA/Change Control).

What We Are Looking For

Required Qualifications

• Bachelor's degree in pharmacy, chemical engineering or equivalent technical field required

• A minimum of 5 (five) years of relevant professional work experience in the field regulated health industry : Cosmetic/Device/Drug regulations environment

• Experience in Quality systems, investigations and CAPA, Doc Management, GxP records Management, Regulatory Compliance.

• Proven experience in leading virtual within dynamic settings in a regional /cross-functional environment. Ideally 3-5 years.

• Solid technical (quality/regulatory) knowledge

• Understanding of LATAM GxP regulations applicable for cosmetics, devices, pharmaceutical industries.

• Advanced English, Spanish Desirable.

Desired Qualifications /Technical competences

• Ability to lead and motivate teams

• Excellent problem-solving and conflict resolution skills

• Consistent track record to work cross-functionally

• Flexibility and adaptability to thrive in a multifaceted environment

• Attention to detail and a drive for ensuring data accuracy and integrity

• Strong demonstrated collaboration, sense of urgency, analytical, influencing skills

• Must be able to develop and maintain relationships/partnerships and to work collaboratively

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