Expert - Product Complaints Job title : Expert of Products Complaints Location: Bogotá, Colombia About the job The purpose of this role is to: Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare. Main responsibilities: Handle Product Technical Complaints and Field Alerts for medical devices, pharmaceutical products, biologics, and combination products, ensuring compliance with regulatory standards. Manage the entire process of handling Product Technical Complaints and Field Alerts from receipt to closure. Collaborate with internal and external manufacturing sites, Customer Service, Medical Information, Pharmacovigilance, Sales Associates, Regulatory, Commercial Operations, Legal, and Risk Management departments. Evaluate complaints for severity and risk, ensuring timely review and processing. Prioritize and enter complaints into the global database, monitoring complaint activity for assigned manufacturing sites. Produce monthly reports for manufacturing sites on complaint activity and support during audits and regulatory inspections. Participate in ad-hoc teams for product-specific complaint issues and provide feedback on complaint investigations. Identify and implement continuous improvement opportunities. Provide regulatory interpretation and guidance to internal teams. Manage and oversee the training within the department. Perform quality checks on PQC activities, prepare reports, and maintain inspection readiness. Manage and ensure the compliance of all Quality processes and documentation with applicable regulations. Assess, evaluate, and follow up on product technical complaints, creating final reports and response letters for authorities. Generate evaluations for early risk detection and trend analysis, supporting the Drug Safety Officer. Participate in creating and presenting presentations, SOPs, and training materials. About you Experience: 8 – 10 years of related experience in the pharmaceutical industry. Knowledge of cGMP's, Code of Federal Regulations in drugs and biologics, and complaint database software and reporting tools. Should be knowledgeable in Quality functions of pharmaceutical industry. Experience of working on manufacturing sites is an added advantage. Required skills: Proficient in problem-solving, attention to detail, and good organizational skills. Work in a team-oriented, flexible, and proactive manner. Analytical skills and ability to multitask in a stressful environment. Education: Masters or Doctorate in Life Sciences/Healthcare, Business Administration, Engineering or Information Technology. Certification in Project Management and/or Lean Six Sigma and/or Continuous Improvement would be preferable. Languages: Excellent knowledge of English language (spoken and written) At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. #J-18808-Ljbffr