Gerente de Sistemas de Gestión de Calidad

About the role

We are looking for a strategic, technically skilled leader to take charge of quality management in a highly regulated operation. The role will ensure that processes, products and equipment meet the highest compliance standards while fostering a culture of continuous improvement.

Key responsibilities

• Direct and monitor the Quality Management System.
• Guarantee compliance with all applicable regulatory requirements and standards.
• Lead internal, client, supplier and regulatory audits.
• Manage deviations, CAPA, change controls, complaints and risk analyses.
• Identify improvement opportunities and drive initiatives that strengthen quality across all areas.
• Guide, develop and support the quality team.

Required profile

• Degree in Pharmaceutical Chemistry, Pharmacy, Chemical Engineering, Biology or related fields.
• Proven experience leading quality areas or teams in regulated industries.
• Strong knowledge of BPM/GMP, BPL/GLP, audit processes and quality system management.
• Ability to make decisions, communicate effectively and influence multidisciplinary teams.
• Intermediate to advanced English (desired).

Required skills

• BPM/GMP
• BPL/GLP
• Audit management
• Quality system management
• CAPA
• Risk analysis

What we offer

• A challenging, stable environment focused on excellence.
• Direct impact on strengthening processes and quality culture.