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J&J Family of Companies SENIOR COMPLIANCE SPECIALIST in Mexico City, Mexico

SENIOR COMPLIANCE SPECIALIST - 2407022377W

Description

Kenvue is currently recruiting for:

Quality Assurance Specialist – Selfcare Franchise Quality

QA Specialist

This position reports into Latam Selfcare Franchise Quality and is based at Mexico City - MX.

Who We Are

At Kenvue (https://kenvue.sharepoint.com/teams/PXEB-EB-assets/Shared Documents/2. Final Assets from Corporate Brand Design/kenvue.com/careers) , 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. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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 (https://www.youtube.com/watch?v=XhsbOsBiX_M) .

What You Will Do

The QA Specialist will be part of the LatAm Franchise Quality organization and is responsible for the quality & compliance oversight for the SelfCare Franchise during all the Product Lifecycle including, but not limited to, the evaluation and risk based analysis of Quality aspects of all 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 for Consumer OTC segment.

  • Provide risk based analysis of Quality aspects related to New Product Introduction and New Business Development

  • Understands 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.

  • Act as a critical voice for opportunities identified in the evaluation of the follow up studies.

  • Ensures 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.

  • Conducts and tracks quality investigations and process deviations and follows up to ensure corrective action has been taken.

  • Develop & qualify new/current service provider/supplier External Service Providers in order to attend regulations and Kenvue requirements.

Qualifications

What We Are Looking For

Required Qualifications

  • Bachelor’s Degree in Pharmacy, Chemistry, Engineering or related science is required. Pharmacy is preferred.

  • Proven experience of at least 6 - 8 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.

  • Advanced knowledge of Microsoft Office (Excel, Power Point, Word).

  • Advanced to Fluent English.

  • Fluent in Spanish.

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, organizational and interpersonal skills.

What’s In It For You

  • Competitive Benefit Package

  • Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

  • Learning & Development Opportunities

  • Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Primary Location Latin America-Mexico-Distrito Federal-Mexico City

Job Function Quality Assurance

Req ID: 2407022377W

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