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