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. #J-18808-Ljbffr

📌 Pharmaceutical Quality Director – Mexico (Tijuana)
🏢 HUNTERS GROUP
📍 Tijuana