Site Quality Director: GMP & Compliance Lead

Organon LLC; Mexico; Hybrid; PHP 6,374,000 - 9,915,000; 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 LLC is hiring a Site Quality Director to ensure GMP-compliant, high-quality products across global markets. You will lead the quality organization, manage the site budget, and drive continuous improvement and regulatory readiness.

The role requires extensive QA leadership experience in pharma, with strong knowledge of NOM-059-SSA1 and SHE, and fluency in Spanish and English. Onsite in Mexico with no relocation support.

Qualifications

• University degree in Pharmacy or Chemistry or related field; master’s degree preferred.
• 10+ years quality management experience in 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; strong leadership and communication skills.

Responsibilities

• Develop and implement QA policies to ensure compliance with Organon policies and global standards.
• Monitor regulatory trends across manufacturing, packaging, supply chain, and operations.
• Ensure product compliance with FDA and other market requirements.
• Lead a robust internal audit program and manage inspections.
• Provide training, guidance, and development for quality staff.

Skills

Leadership experience

GMP/GxP knowledge

Regulatory compliance

Quality Management

Executive leadership

Training and guidance

Process improvement

Education

University degree in Pharmacy, Chemistry, or related field

Master’s degree in Pharmaceutical Sciences, Regulatory Affairs, Public Health, Quality Assurance or related (preferred)

Job description

Organon LLC is hiring a Site Quality Director to ensure GMP-compliant, high-quality products across global markets. You will lead the quality organization, manage the site budget, and drive continuous improvement and regulatory readiness.

The role requires extensive QA leadership experience in pharma, with strong knowledge of NOM-059-SSA1 and SHE, and fluency in Spanish and English. Onsite in Mexico with no relocation support.