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 integral 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)

📌 Jefe de Calidad Comercial (Santa Fe)
🏢 Takeda
📍 Santa Fe