Area Quality Specialist

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 global 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 regulated healthcare industries Knowledge of Integrated Management Systems (IMS), Good Manufacturing Practices (GMP), and Corrective and Preventive Actions (CAPA) Familiarity with Colombian regulatory requirements for Medical Devices and Pharmaceuticals Ability to work in a hybrid arrangement at the Solventum office and the 3PL in Cundinamarca May include up to 10% travel in country Core Competencies Demonstrates 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 keywords Quality Management Systems (QMS) Good Distribution Practices (GDP) Regulatory Affairs Experience Internal Audits and Risk Assessments Corrective and Preventive Actions (CAPA) ATS Optimization Keywords Hard Skills Quality Performance Monitoring Data Analysis Change Control Management Regulatory Inspections Integrated Management Systems (IMS) Good Manufacturing Practices (GMP) Employee Training on QMS CAPA Development and Implementation Risk Assessment Documentation Compliance Soft Skills Effective Communication Cross-Functional Leadership Organizational Skills Problem-Solving Collaboration Certifications & Qualifications Bachelor’s Degree in Pharmacy Pharmaceutical Sciences Life Sciences Healthcare Industry Keywords Medical Devices Pharmaceutical Regulations Colombian Regulatory Requirements Good Storage Practices Good Transportation Practices #J-18808-Ljbffr