Jefe de Calidad Comercial

Takeda; Santa Fe; Presencial; MXN 900.000 - 1.400.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Meal allowance

Supermarket vouchers

Saving Fund

Healthcare (life, medical, dental, and

Paid time off

DEI programs

Descripción de la vacante

Takeda in Mexico City is seeking a Quality Operations Supervisor to oversee process quality, drive regulatory compliance, and lead a small team. The role requires strong QA/QA Operations background in regulated environments, expertise in CAPA, QMS, and data analysis, and collaboration across functions to deliver high-quality outputs.

Responsibilities include defining quality standards, auditing processes, and ensuring COFEPRIS alignment.

Formación

• Minimum 5–6 years as sanitary responsible or similar, with COFEPRIS representation.
• Bachelor's or higher degree in Pharmaceutics or related.
• Experience in QA/Quality Operations within regulated environments (biotech/pharma) and managing high-cost pharmaceutical products.
• Strong auditing, CAPA, and QMS expertise.
• Proficiency in SAP is preferred.
• Fluent business and technical English.
• Experience coordinating team responsibilities and cross-functional stakeholders.
• Ability to analyze quality data and identify trends, risks, deviations.
• Solid understanding of regulatory compliance standards and change control processes.

Responsabilidades

• Define and implement quality standards, processes, and procedures to meet regulatory and internal requirements
• Audit and monitor processes and outputs, identifying risks, deviations, and improvement opportunities
• Conduct product integrity testing to ensure compliance with quality expectations
• Analyze quality data and prepare reports on defects, deviations, and trends
• Lead Corrective and Preventive Action processes and change control activities
• Ensure adherence to Quality Management Systems and regulatory frameworks
• Drive continuous improvement initiatives to optimize quality performance
• Lead, coach, and develop a small team, including performance reviews and resource planning
• Provide technical guidance and support to enhance quality-related capabilities

Conocimientos

Quality Assurance

CAPA

Quality Management Systems

English (Fluent)

Cross-functional coordination

Data analysis

Regulatory compliance

Stakeholder management

Educación

Bachelor's or higher in Pharmaceutics or related

Herramientas

SAP

Descripción del empleo

Job Description

THE OPPORTUNITY

The Quality Operations Supervisor is responsible for overseeing the quality of processes and product outputs, ensuring compliance with internal standards and regulatory requirements.

This role plays a key part in driving operational excellence by monitoring performance, mitigating risks, optimizing processes, as well as coordinating and overseeing the rest of the activities focused on delivering high-quality outcomes aligned with Takeda’s global standards.

Additionally, this position has a critical responsibility as Responsible Sanitary Representative for warehouse operations, acting before regulatory authorities and ensuring all licenses and quality processes meet COFEPRIS requirements.

MAIN RESPONSIBILITIES:

• Define and implement quality standards, processes, and procedures to meet regulatory and internal requirements




• Audit and monitor processes and outputs, identifying risks, deviations, and improvement opportunities




• Conduct product integrity testing to ensure compliance with quality expectations




• Analyze quality data and prepare reports on defects, deviations, and trends




• Lead Corrective and Preventive Action processes and change control activities




• Ensure adherence to Quality Management Systems and regulatory frameworks




• Drive continuous improvement initiatives to optimize quality performance




• Lead, coach, and develop a small team, including performance reviews and resource planning




• Provide technical guidance and support to enhance quality-related capabilities

SKILLS & QUALIFICATIONS:

• 5-6 minimum years of experience as sanitary responsible or related positions with past representation at COFEPRIS




• Mandatory Bachelors or Higher Educational Degree in Pharmaceutics or related




• Proven experience in Quality Assurance / Quality Operations within regulated environments (biotech/pharma) as well as managing ideally high-cost pharmaceutical products




• Strong expertise in auditing, CAPA, and Quality Management Systems (QMS)




• Proficiency in SAP is also preferred




• Fluent business and technical English language level




• Experience coordinating team responsibilities and proactively managing different stakeholders cross-functionally




• Ability to analyze quality data and identify trends, risks, and deviations




• Solid understanding of regulatory compliance standards and change control processes

WHAT TAKEDA OFFERS:

At Takeda, you take the lead in shaping your career. Joining our team in Mexico City provides access to:

• Competitive salary + annual performance bonus




• Monthly meal allowance & supermarket vouchers




• Saving Fund




• Comprehensive healthcare packages (life, medical, dental, vision)




• Additional paid time off




• Strong Diversity, Equity & Inclusion licenses and programs

Locations

MEX - Santa Fe

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time