Join to apply for the Gerente QRA, Dirección Técnica Colombia role at Messer Americas . Messer is the largest private industrial gases company in the world and a leading provider of industrial and medical gases in North and South America. With over 120 years of experience, Messer delivers gases, services, and technologies safely through an extensive production and distribution network. Job Description The role involves leading quality management and regulatory affairs in Colombia, ensuring compliance with health and regulatory standards for medicinal gases and medical devices. Responsibilities include obtaining and maintaining health registrations, certifications, traceability, and implementing quality and safety management systems to position the company as a sector leader. Responsibilities 1. Ensure compliance with quality assurance activities across manufacturing plants, storage, and distribution of medicinal gases and medical devices, in accordance with Good Manufacturing Practices (GMP), Medical Healthcare Requirements, and applicable legislation. 2. Lead and maintain health registrations for medicinal gases and medical devices in the country. 3. Collaborate with operations to implement local and global quality and regulatory standards. 4. Support business areas according to Messer's global standards and local regulations. 5. Implement and monitor policies and strategic plans for manufacturing, distribution, and patient-related services in the region. 6. Oversee surveillance programs (Fármaco-Tecno). 7. Advise the legal representative on product characteristics and marketing, ensuring compliance with current regulations. 8. Ensure ongoing staff training on GMP and CCAA standards. 9. Guarantee product traceability and compliance with surveillance programs for medical devices and medicines. 10. Act as the Technical Director of Messer Colombia S.A. before health authorities. 11. Collaborate with regulatory bodies to improve product control processes. 12. Manage personnel performance according to company standards. 13. Develop regulatory strategies for product registration and marketing. 14. Oversee batch release processes, ensuring traceability and proper record keeping. 15. Delegate batch release tasks to Quality Managers as appropriate. 16. Design and implement a food safety management system under FSSC 22001 standards, ensuring continuous improvement. 17. Maintain and update the food safety management documentation. 18. Participate in hazard identification and assessment for product safety. 19. Maintain updated documentation on food safety legislation and monitor legal compliance. 20. Coordinate food safety team meetings. HSEQ Responsibilities - Use personal protective equipment according to activity. - Apply company HSEQ procedures and standards. - Participate in HSEQ programs. - Follow HSEQ rules of the company. Qualifications - Minimum six (6) years of experience in quality and regulatory affairs, with at least four (4) years in regulatory procedures before INVIMA and other health entities. Formal Education: Bachelor’s degree in Pharmaceutical Chemistry. Postgraduate: Production or quality, preferably a Master’s degree. Required Certifications: Auditor certification. Specific Knowledge: Quality assurance, implementation of quality management systems, Good Manufacturing Practices, regulatory affairs, and health authority procedures. Messer Americas is committed to fostering a culture that promotes diversity and inclusion. We value our employees as our most valuable resource and strive to develop a diverse and inclusive organization. If you meet the requirements and are interested in joining our team, we invite you to apply and take on this new professional challenge. #J-18808-Ljbffr