Director Técnico

About the Company

Leading company committed to quality, innovation, and regulatory compliance to ensure the safety and efficacy of our products.

Requirements

• Licensed Pharmaceutical Chemist, with a valid professional card and current authorization as Technical Director before INVIMA.
• Advanced English for handling technical documentation and communication in international audits.
• Minimum 5 years of experience in similar roles within the regulated pharmaceutical or food industry.
• Solid knowledge and experience in standards such as GMP (Colombian and EU-GMP), HACCP, ISO 22000, BRCGS, and experience with FDA or EMA audits.
• Strong background in document management, process validations, traceability, deviation handling, and CAPAs.
• Understanding of production processes, maintenance, and industrial HSE (occupational safety, biosafety, and waste management).
• Proven ability to lead plant recertification processes and prepare for national and international inspections.
• Demonstrated leadership and team supervision skills.

Responsibilities

• Lead and manage the sanitary recertification process of the plant under INVIMA and EU-GMP standards.
• Ensure compliance with national and international quality regulations and Good Manufacturing Practices.
• Oversee documentation systems, operational procedures, and validation plans.
• Coordinate internal and external audits, and ensure the site is fully prepared for upcoming international inspections.
• Maintain and improve the Quality Assurance Systems, ensuring traceability and control of deviations.
• Collaborate with production, quality, maintenance, and HSE teams to guarantee safe and efficient operations.
• Report directly to management and supervise the assigned technical team.