Pharmaceutical Quality Director – Mexico

Hace 23 horas

estado de mexico mexico, State of Mexico Hunters Group Jornada completa

Pharmaceutical Quality Director – Mexico

HUNTERS GROUP

Location: Mexico City / State of Mexico

Industry: Pharmaceutical Manufacturing / Life Sciences

Level: Executive Management

Position Overview

We are seeking an experienced Pharmaceutical Quality Director to lead quality assurance, quality control, and regulatory compliance for a major pharmaceutical manufacturing operation in Mexico.

The successful candidate will ensure manufacturing compliance, product integrity, regulatory readiness, and continuous improvement across pharmaceutical production facilities.

Key Responsibilities

  • Lead Quality Assurance, Quality Control, and Quality Systems.
  • Ensure compliance with COFEPRIS, NOM-059, GMP, and applicable international regulatory standards.
  • Oversee batch release processes, manufacturing deviations, investigations, and CAPA programs.
  • Lead regulatory inspections and corporate quality audits.
  • Manage product quality risks, validation programs, and contamination control.
  • Direct quality teams, laboratories, and compliance initiatives.
  • Maintain inspection readiness and ensure product supply continuity.
  • Report directly to senior executive leadership.

Qualifications

  • Bachelor's degree in Pharmaceutical Chemistry, Pharmacy, Chemistry, or related field.
  • Advanced degree preferred.
  • 12+ years of experience in pharmaceutical manufacturing and quality management.
  • Minimum 5 years in senior quality leadership.
  • Extensive knowledge of GMP, NOM-059, COFEPRIS, and pharmaceutical validation.
  • Proven experience managing regulatory inspections and quality audits.
  • Strong leadership of multidisciplinary technical teams.