Jefe de Calidad Comercial
Takeda
Zapotlán, Estado de México, México
Full-Time
Competitive
OfficeManager
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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 RESPONSABILITIES:
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