Technical Director/Manager

About the role

We are a leading pharmaceutical company seeking a Technical Director to oversee technical, quality and regulatory operations across our manufacturing sites in Barranquilla. The role ensures compliance with global standards, protects patient safety and drives continuous improvement.

Key responsibilities

• Act as the Technical Responsible Person before regulatory authorities.
• Ensure GMP, GLP and all applicable pharmaceutical regulations are met.
• Lead Quality Assurance, Quality Control and Technical Operations teams.
• Approve product releases and manage investigations related to deviations, CAPA, OOS/OOT, complaints and recalls.
• Lead regulatory inspections, audits and interactions with health authorities such as the FDA.
• Support regulatory submissions, technical documentation and manufacturing compliance activities.
• Drive continuous improvement initiatives to strengthen quality systems and operational performance.

Required profile

• Bachelor’s degree in Pharmaceutical Chemistry.
• Post‑graduate specialization or Master’s in Quality, Manufacturing, Regulatory Affairs, Industrial Processes or Business Administration.
• 10+ years of experience in pharmaceutical manufacturing, with proven leadership of technical affairs, quality assurance and quality control.
• Experience interacting with regulatory agencies (e.g., FDA) and managing inspections and audits.
• Fluent English (C1) and willingness to travel as needed.

Required skills

• GMP and GLP compliance.
• CAPA management.
• OOS/OOT investigations.
• Product release processes.
• Regulatory inspections and audits.
• FDA interaction.