Sr Manager, Quality & Responsable Sanitario

Novo Nordisk; Ciudad de México; Presencial; MXN 1.800.000 - 3.000.000; Jornada completa

Descripción de la vacante

Novo Nordisk in Mexico City seeks a Senior Manager, Quality & Responsable Sanitario to lead the QA team and act as the highest quality authority for COFEPRIS. You will ensure product quality, drive compliance, and partner with the business during a growth phase.

You will oversee QA processes, 3PL quality, and regulatory affairs, while guiding a high-performing team and shaping the quality strategy across the affiliate.

Formación

• Experience leading QA teams in pharmaceutical manufacturing or distribution.
• Deep knowledge of GxP, COFEPRIS, and regulatory inspections.
• Proven capability to manage budgets and develop talent.

Responsabilidades

• Lead QA team in Mexico affiliate; ensure compliance with Novo Nordisk procedures and local requirements.
• Oversee QMS processes (change control, deviations, CAPAs, document control, audits, GxP IT).
• Act as Responsable Sanitario per NOM-059 and collaborate with senior leadership.
• Manage quality oversight of 3PL operations and cold chain compliance.
• Assess quality risks; drive mitigation and escalate when needed.
• Lead regulatory interactions with COFEPRIS during inspections/requests.
• Serve on Local Product Protection Committee; address counterfeit and diversion cases.
• Drive process optimization and digitalization of quality operations.

Conocimientos

QA Leadership

GxP & COFEPRIS

Regulatory liaison

English & Spanish

Budget & people leadership

Educación

Licenciado en Farmacia / Químico Farmacéutico

Regulatory affairs training

Descripción del empleo

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 Global 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 & Security Director and lead the Quality Assurance function. Your team plays a critical role in safeguarding product integrity across an expanding portfolio, partnering closely with Supply Chain, Regulatory affair, Commercial teams and external stakeholders to ensure patients receive safe and compliant medicines every day.

Your Skills & Qualifications

We are looking for a quality leader who combines deep pharmaceutical expertise with the credibility and regulatory standing to represent Novo Nordisk before COFEPRIS. You will bring:

• A degree as Licenciado en Farmacia, Químico Farmacéutico, Químico Farmacéutico Biólogo or Químico Farmacéutico Industrial , to meet Responsable Sanitario eligibility requirements for a Pharma company.


• Minimum 10 years of experience in pharmaceutical quality, with strong knowledge of local regulation, GxP, QMS processes and cold chain product management


• 5+ years of people leadership experience, with a track record of developing teams and driving a culture of continuous improvement


• Experience overseeing 3PL quality compliance and managing quality agreements


• A process optimisation mindset with interest in driving more efficient and digital ways of working


• Strong collaboration skills, particularly across Quality and Supply Chain functions


• Fluency in English and Spanish

Working at Novo Nordisk

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long‑term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What We Offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline: 3 September 2025. Applications are reviewed on an ongoing basis.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long‑term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.