Site Quality Director: GMP, Compliance & Regulatory Excellence

Organon LLC; Xochimilco; On-site; MXN 2,000,000 - 3,000,000; Full time

Benefits offered by this job

Attractive base salary

Work-life balance initiatives

Direct Contract with Superior Benefits

Learning and development opportunities

Job summary

Organon LLC in Xochimilco, Mexico, seeks a Site Quality Director to ensure GMP compliance, regulatory readiness, and continuous improvement of QA processes onsite. You will lead internal audits, manage data systems, and oversee the quality budget to align with business needs.

The ideal candidate holds a pharmacy degree with 10+ years in pharmaceutical quality, 5+ years leading a team of at least five, and 3+ years in executive roles.

Qualifications

• Completed University degree in Pharmacy, Chemistry, or related field.
• 10+ years of experience in quality management within the pharmaceutical industry.
• 5+ years leading a team of at least 5 direct reports.
• 3+ years in executive roles (Sr. Manager or Director Level).
• Fluency in Spanish and English, both oral and written.

Responsibilities

• Develop and implement QA policies and procedures to ensure GMP compliance.
• Review and respond to regulatory trends affecting manufacturing and operations.
• Ensure product compliance with FDA/regulatory requirements in markets served.
• Lead internal audits and maintain robust data management systems.
• Drive continuous improvement to optimize quality processes and productivity.
• Lead and empower the quality organization and manage the budget.

Skills

Quality management

GMP knowledge

Leadership

Problem solving

Bilingual English/Spanish

Education

Pharmacy degree

Master’s preferred

Job description

Organon LLC in Xochimilco, Mexico, seeks a Site Quality Director to ensure GMP compliance, regulatory readiness, and continuous improvement of QA processes onsite. You will lead internal audits, manage data systems, and oversee the quality budget to align with business needs.

The ideal candidate holds a pharmacy degree with 10+ years in pharmaceutical quality, 5+ years leading a team of at least five, and 3+ years in executive roles.