Site Quality Director - GMP, Regulatory & Continuous Improvement

Organon Latam; Ciudad de México; Presencial; MXN 1.600.000 - 2.100.000; Jornada completa

Descripción de la vacante

Organon Latam seeks a Site Quality Director to ensure compliance with Organon policies and global standards. You will lead QA, manage regulatory trends, and drive continuous improvement, audits, and data systems. Responsible for the quality org and budget, reporting to senior leadership.

The role emphasizes GMP/GxP expertise, leadership, and strong cross-functional collaboration in a fully onsite setting in Mexico City.

Formación

• Ten+ years in pharmaceutical quality management.
• Five+ years leading a team of at least five people.
• Three+ years in executive roles (Sr. Manager/Director).
• Strong knowledge of NOM-059-SSA1, SHE, GMP and regulatory standards.
• Fluency in Spanish and English; excellent communication.

Responsabilidades

• Develop and implement QA policies aligned with Organon standards.
• Lead internal audits and manage regulatory inspections.
• Drive continuous improvement in quality systems and processes.
• Oversee budget and resources for the quality organization.
• Provide training and guidance to staff and stakeholders.

Conocimientos

Leadership

Quality management

GMP/GxP

Regulatory affairs

Communication skills

Bilingual EN/ES

Educación

Pharmacy degree

Master’s in Pharmaceutical Sciences or Regulatory Affairs

Descripción del empleo

Organon Latam seeks a Site Quality Director to ensure compliance with Organon policies and global standards. You will lead QA, manage regulatory trends, and drive continuous improvement, audits, and data systems. Responsible for the quality org and budget, reporting to senior leadership.

The role emphasizes GMP/GxP expertise, leadership, and strong cross-functional collaboration in a fully onsite setting in Mexico City.