- Manage and govern the company’s ENOVIA document control system, ensuring review-step compliance with local requirements
- Monitor, analyze, and drive performance against key quality KPIs
- Lead cross-functional investigations and manage CAPA development, implementation, and effectiveness monitoring
- Conduct annual site risk assessments
- Develop, execute, and oversee internal audit and self-inspection programs
- Support external audits according to Technical Director instructions and integral procedures
- Deliver employee training and qualification programs on QMS requirements and quality processes
- Partner with the Technical Director to ensure compliance with regulatory, quality, and operational requirements
- Support product release activities, including oversight of Certificates of Analysis and related quality documentation
- Manage change control processes, including documentation, impact assessment, implementation, and effectiveness tracking
- Act as designated backup for the Technical Director




- Undertake additional responsibilities assigned by management to support organizational priorities and continuous improvement

Requirements
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Healthcare, or a related field, completed and verified before the start date
- Minimum of three (3) years of experience maintaining Quality Management Systems (QMS) and Good Distribution Practices (GDP) within Medical Devices and/or Pharmaceutical environments
- Intermediate to advanced English proficiency, with the ability to communicate effectively in a global environment
- Strong knowledge of Medical Device and Pharmaceutical regulations, including Good Storage, Distribution, and Transportation Practices
- Experience conducting internal audits, risk assessments, CAPA management, change controls, and regulatory inspections
- Statistics and data analysis for quality performance monitoring and continuous improvement
- Experience in Regulatory Affairs within r

📌 Area Quality Specialist (Bogotá, D.C.)
🏢 Jobtailor
📍 Bogotá, D.C.