Quality Operations Supervisor – Regulated Pharma

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

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.