Site Quality Director – Onsite in Xochimilco

About the role

As the Site Quality Director you will lead the quality function at our Xochimilco facility, ensuring that all products meet Organon policies, global industry standards, and local regulatory requirements. You will drive continuous improvement, manage internal audits, and oversee the quality budget to support business objectives.

Key responsibilities

• Develop and implement quality assurance policies and procedures aligned with Organon and global standards.
• Monitor and incorporate local and international regulatory trends (e.g., FDA, COFEPRIS) into manufacturing, packaging, and supply‑chain processes.
• Guarantee product quality, efficacy, and safety, including oversight of outsourced services through quality agreements.
• Foster a culture of continuous improvement to enhance productivity and service levels.
• Maintain a robust internal audit program and ensure readiness for regulatory inspections.
• Provide training, mentorship, and technical guidance to the quality team.
• Oversee physical and electronic data management systems, including technical documentation and annual product reviews.
• Manage the quality area budget and align resources with departmental priorities.

Required profile

• University degree in a relevant scientific or engineering discipline.
• Extensive experience in GMP‑compliant environments, preferably within the pharmaceutical industry.
• Proven leadership experience managing quality teams and budgets.
• Strong understanding of regulatory frameworks such as FDA and COFEPRIS.

Required skills

• Good Manufacturing Practices (GMP)
• Regulatory compliance (FDA, COFEPRIS)
• Quality management systems
• Internal audit execution
• Data management and technical documentation

What we offer

• Opportunity to lead quality excellence at a major pharmaceutical site.
• Collaborative environment focused on innovation and continuous improvement.