25 ago
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Novo Nordisk
|
Ciudad de México
25 ago
Novo Nordisk
Ciudad de México
Senior Manager, Quality & Responsable Sanitario
Mexico City, Mexico
Shape the quality standards that protect patients across one of Novo Nordisk's most dynamic markets and serve as the trusted voice to Mexico's health authority.
Your new role
As Senior Manager, Quality & Responsable Sanitario, you will lead the Quality Assurance team in our Mexico affiliate while serving as the highest-ranking quality authority recognised by COFEPRIS. You will ensure product quality, drive compliance across internal and external requirements, and act as a strategic quality partner to the business during a period of significant growth and operational transformation.
Your Key Responsibilities Will Include
Leading and developing the QA team, managing budgets, resource planning, performance evaluation and training to build a high-performing, future-ready department
Overseeing day-to-day quality compliance with Novo Nordisk global procedures and local health authority requirements, including QMS subprocesses such as change control, deviations, CAPAs, document control, audits and GxP IT systems
Acting as Responsable Sanitario per NOM-059, holding the highest hierarchical quality position and making decisions on GxP matters in collaboration with senior leadership
Managing quality oversight of 3PL operations, including cold chain compliance – particularly following the recent logistics partner transition
Assessing quality risks, driving mitigation actions, and escalating issues to Emerging Markets Region and Integral Quality as needed
Leading interactions with COFEPRIS during inspections, regulatory requests and communications
Serving as a member of the Local Product Protection Committee, analysing counterfeit, diversion and product theft cases and agreeing on mitigation actions
Driving process optimisation and exploring more efficient, digital ways of working across quality operations
Your new department
Within our Mexico affiliate, you will report to the Legal, Ethics, Quality & Sec
📌 Sr Manager, Quality (Ciudad de México)
🏢 Novo Nordisk
📍 Ciudad de México