Onsite Site Quality Director: GMP, Compliance & Improvement

Organon Latam; Xochimilco; On-site; MXN 180,000 - 240,000; Full time

Benefits offered by this job

Attractive base salary

Work-life balance initiatives

Workplace perks

Direct contract with superior benefits

Learning and development opportunities

Job summary

Organon Latam in Mexico City seeks a Site Quality Director to ensure GMP compliance, oversee quality systems, and drive continuous improvement. You will manage internal audits, data systems, and regulatory alignment for products across markets.

The role requires extensive experience in pharmaceutical quality management, leadership of a team, and strong regulatory knowledge, with full onsite work in Xochimilco area. Fluency in Spanish and English is essential.

Qualifications

• Degree in Pharmacy, Chemistry or related field with regulatory emphasis preferred.
• 10+ years in quality management within pharma.
• 5+ years leading teams; 3+ years in executive roles.
• Strong NOM-059-SSA1, SHE, GMP/GxP knowledge.
• Fluency in Spanish and English (oral and written).

Responsibilities

• Develop and implement QA policies to ensure compliance with Organon policies and global standards.
• Monitor regulatory trends in manufacturing, packaging, supply chain, and operations.
• Ensure products meet regulatory requirements in all markets including FDA guidelines.
• Maintain robust internal audits and training for QA personnel.
• Lead quality team and manage quality area budget.

Skills

Quality management

GxP awareness

Leadership

Regulatory knowledge

Bilingual English/Spanish

Education

University degree in Pharmacy or Chemistry

Master’s in Pharmaceutical Sciences/Regulatory Affairs preferred

Job description

Organon Latam in Mexico City seeks a Site Quality Director to ensure GMP compliance, oversee quality systems, and drive continuous improvement. You will manage internal audits, data systems, and regulatory alignment for products across markets.

The role requires extensive experience in pharmaceutical quality management, leadership of a team, and strong regulatory knowledge, with full onsite work in Xochimilco area. Fluency in Spanish and English is essential.