Manage and govern the company's ENOVIA document control system, ensuring review-step compliance with local requirementsMonitor, analyze, and drive performance against key quality KPIsLead cross-functional investigations and manage CAPA development, implementation, and effectiveness monitoringConduct annual site risk assessmentsDevelop, execute, and oversee internal audit and self-inspection programsSupport external audits according to Technical Director instructions and general proceduresDeliver employee training and qualification programs on QMS requirements and quality processesPartner with the Technical Director to ensure compliance with regulatory, quality, and operational requirementsSupport product release activities, including oversight of Certificates of Analysis and related quality documentationManage change control processes, including documentation, impact assessment, implementation, and effectiveness trackingAct as designated backup for the Technical DirectorUndertake additional responsibilities assigned by management to support organizational priorities and continuous improvementRequirementsBachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Healthcare, or a related field, completed and verified before the start dateMinimum of three (3) years of experience maintaining Quality Management Systems (QMS) and Good Distribution Practices (GDP) within Medical Devices and/or Pharmaceutical environmentsIntermediate to advanced English proficiency, with the ability to communicate effectively in a global environmentStrong knowledge of Medical Device and Pharmaceutical regulations, including Good Storage, Distribution, and Transportation PracticesExperience conducting internal audits, risk assessments, CAPA management,



change controls, and regulatory inspectionsStatistics and data analysis for quality performance monitoring and continuous improvementExperience in Regulatory Affairs within regulated healthcare industriesKnowledge of Integrated Management Systems (IMS), Good Manufacturing Practices (GMP), and Corrective and Preventive Actions (CAPA)Familiarity with Colombian regulatory requirements for Medical Devices and PharmaceuticalsAbility to work in a hybrid arrangement at the Solventum office and the 3PL in CundinamarcaMay include up to 10% travel in countryCore CompetenciesDemonstrates expertise in managing Quality Management Systems (QMS) and ensuring compliance with regulatory requirements in the pharmaceutical and medical device sectors.
Proficient in conducting audits, risk assessments, and CAPA management to drive continuous improvement and maintain quality standards.Highest-signal resume keywordsQuality Management Systems (QMS)Good Distribution Practices (GDP)Regulatory Affairs ExperienceInternal Audits and Risk AssessmentsCorrective and Preventive Actions (CAPA)ATS Optimization KeywordsHard SkillsQuality Performance MonitoringData AnalysisChange Control ManagementRegulatory InspectionsIntegrated Management Systems (IMS)Good Manufacturing Practices (GMP)Employee Training on QMSCAPA Development and ImplementationRisk AssessmentDocumentation ComplianceSoft SkillsEffective CommunicationCross-Functional LeadershipOrganizational SkillsProblem-SolvingCollaborationCertifications & QualificationsBachelor's Degree in PharmacyPharmaceutical SciencesLife SciencesHealthcareIndustry KeywordsMedical DevicesPharmaceutical RegulationsColombian Regulatory RequirementsGood Storage PracticesGood Transportation Practices
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📌 Area Quality Specialist (Bogotá)
🏢 Jobtailor
📍 Bogotá