ANALISTA SR DE CALIDAD - Fixed Term

ANALISTA SR DE CALIDAD - Fixed Term

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to:

COORD QA

Location:

Latin America, Mexico, Distrito Federal, Mexico City

Work Location:

Hybrid

What you will do

The Analista Sr de Calidad – Source Quality will be part of the LatAm Source Quality organization and is responsible for the quality & compliance oversight for the External Suppliers and projects including, but not limited to, the evaluation and risk-based analysis of Quality aspects of New Product Introduction, Business Development and Changes to Existing Products.

Key Responsibilities

• Participate in local and regional quality/compliance projects and act as the Quality voice for New Product Introduction and New Business Development in LATAM. Guarantee project’s activities are completed on time.
• Ensure projects’ compliance, accuracy, and alignment with company policies, procedures and quality standards.
• Provide risk-based analysis of Quality aspects related to New Product Introduction and New Business Development
• Understand current and emerging regulations and impact to quality of OTC keeping affiliates/EM located in other regions updated and compliant on new regulations.
• Partner with adjacent areas of the business to build a robust strategy to achieve the committed goals.
• Ensure all products meet and/or exceed company and local government standards evaluating regulations to provide risk analysis guidance and make decisions about GxP activities accurately.
• Lead external audits, supplier’s selection, qualification and monitoring tasks to attend regulations and Kenvue requirements.
• Collaborate cross-functionally with engineering, product, operations, and other quality teams to embed quality-centric practices, update and improve documentation including standard operating procedures, external supplier documents (including process validation, analytical transfers), and support new product development procedures throughout the development lifecycle.

What we are looking for

Required Qualifications

• Bachelor’s degree or equivalent in Engineering, Computer Science, Data Analytics, or a related field
• Proven experience of at least 4 - 6 years in a regulated industry. Pharmaceutical Industry is preferred.
• Knowledge in Drug Product Manufacturing and Controls.
• Knowledge on regulatory requirements across LatAm region such as ANVISA, COFEPRIS, INVIMA, ANMAT.
• Working knowledge of CAPA, Change Control, and General Quality Systems process.
• Knowledge in Process Validation.
• Knowledge in Process/Analytical Transfers.
• Strong foundational knowledge of quality management principles
• Effective communication skills to collaborate with cross-functional teams and support quality initiatives.
• Strong analytical and problem-solving skills with experience in interpreting data and generating quality reports.
• Advanced knowledge of Microsoft Office (Excel, Power Point, Word).
• Advanced to Fluent English.

Desired Qualifications

• Basic to Intermediate Portuguese.
• Advanced technical training and experience using Statistics, Lean and Six Sigma Methodologies.
• Strong analytic skills – Ability to standardize varying data process/inputs.
• Intellectual agility, curiosity, and creativity.
• Good communication skills to effectively articulate quality insights and influence stakeholders at all organizational levels.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.