
Posted 20 days ago
Senior Quality Analyst
KenvueAnalista Sr de Calidad
Requirements
Bachelor's degree in Engineering, Computer Science, or Data Analytics, 4-6 years experience in a regulated industry, Knowledge of Drug Product Manufacturing and Controls, Knowledge of LatAm regulations (ANVISA, COFEPRIS, INVIMA, ANMAT), Working knowledge of CAPA and Change Control, Knowledge in Process Validation and Analytical Transfers, Advanced Microsoft Office skills, Advanced to Fluent English
Skills
quality managementGMPSix SigmaQuality ControlLean ManufacturingQuality Assurance
About the role
Responsibilities
- Provide quality and compliance oversight for external suppliers and projects in the LATAM region.
- Perform risk-based analysis for New Product Introductions (NPI), Business Development, and changes to existing products.
- Act as the Quality voice for regional projects, ensuring all activities are completed on time and align with company policies.
- Monitor and interpret emerging regulations to keep affiliates and external manufacturers compliant.
- Lead external audits, supplier selection, qualification, and ongoing monitoring tasks.
- Collaborate cross-functionally with engineering, operations, and product teams to improve documentation, including SOPs, process validations, and analytical transfers.
Requirements
- Bachelor's degree in Engineering, Computer Science, Data Analytics, or a related field.
- 4-6 years of experience in a regulated industry (Pharmaceutical industry preferred).
- Strong knowledge of Drug Product Manufacturing and Controls.
- Familiarity with LatAm regulatory requirements, including ANVISA, COFEPRIS, INVIMA, and ANMAT.
- Working knowledge of CAPA, Change Control, and General Quality Systems.
- Experience with Process Validation and Process/Analytical Transfers.
- Advanced proficiency in Microsoft Office (Excel, PowerPoint, Word).
- Advanced to fluent English communication skills.
Preferred Qualifications
- Basic to intermediate Portuguese language skills.
- Technical training and experience using Statistics, Lean, and Six Sigma methodologies.
- Strong analytical skills with the ability to standardize varying data processes and inputs.
About the Company
Kenvue is a global leader in consumer health, home to iconic brands such as NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S®, and BAND-AID®. Rooted in science and driven by a passion for care, we aim to impact millions of lives every day through everyday care products.
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Kenvue · Mexico City
