Technical Director (Director Técnico)

Job Overview:
The Director Técnico / Qualified Person is legally responsible for ensuring that every batch of a pharmaceutical product is manufactured and controlled according to Good Manufacturing Practices (GMP) and the product's sanitary registration.

Duties and Responsibilities:
Design, implementation of the local Quality Management System (QMS) for our client, including governance of deviations, CAPAs, change control, complaints management, and product recalls. Oversight of GMP and GDP compliance across all local operations, including effective quality oversight of third‑party partners and service provider in Colombia. Ensuring alignment between global Quality standards and local regulatory requirements, translating global policies into effective local execution.

Required Qualifications:
Must be a Químico Farmacéutico (Pharmaceutical Chemist) registered in Colombia and will be the primary point of contact with INVIMA for all technical and quality matters.

Educational Background:
Químico Farmacéutico (Pharmaceutical Chemist)

Experience:
7-10+ years of experience (as Qualified Person as well) within GMP and GDP‑regulated biotech and/or pharmaceutical companies with demonstrated excellent hands‑on experience with both solid and sterile pharmaceutical products.

Languages:
Fluency in both English and Spanish, with the capability to communicate clearly and professionally in regulatory, operational, and cross‑functional contexts.

Additional Notes:
Must be a dedicated, excellent and highly collaborative team player, demonstrating strong ownership, reliability, and the ability to work effectively across global and local stakeholders. Proven experience working within an affiliate model as an importer, including close collaboration with distributors and external partners. Demonstrated ability to establish and operate a local Quality Management System fully aligned with both local regulatory requirements and global quality governance expectations.