Country Clinical Quality Management

Country Clinical Quality Management - Argentina Job Description It is critical that, for all our Company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The CCQM position has a significant impact in achieving those objectives. Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM activities in the respective country/cluster. The role requires the ability to properly implement local/global processes/procedures, identify opportunities for process improvement, and support continuous improvement initiatives. In addition, the CCQMs support audits, inspections, as well as Quality Control and local training activities. Position Responsibilities Primary responsibilities for this position include, but are not limited to: Regulations & Processes Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes). In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs). Local expert for any quality-related local processes. Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary). Leads continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM and supports or co-leads continuous improvements activities at the global/regional level. Training Local training point of contact and the liaison between local country operations and Research & Development Division Learning & Development (L&D). In close cooperation with local country operations management, identifies / coordinates local training needs. Supports local trainings (as needed). Quality Control (QC) Activities In conjunction with the local country operations management, coordinates and oversees all QC activities. This includes ensuring a proper execution of the In-house Quality Control Plan (IHQCP), the Quality Control Visits (QCVs) as well as any other QC Checks. In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request. On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary), develops local action plan (incl. sharing of results and training of local country operations, if required). Audits & Inspections Primary local point of contact for our Research & Development Division Quality Assurance and Regulatory Agencies. Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection. In cooperation with local country operations and/or headquarters, performs root-cause-analysis for audit observations/inspection findings, manages and tracks the Corrective and Preventive Actions (CAPAs) and coordinates/facilitates the responses to audit/inspection reports. On a regular basis and in collaboration with local country operations, identifies local trends, performs root-cause-analysis (if necessary) and develops local action plan (incl. sharing of results and training of local country operations, if required). Quality/Compliance/Privacy Escalation Communicates and escalates issues and trends to local Operations and RCQM. Escalates significant issues, supports investigations (fact finding, root cause analysis), and reports Serious Breaches when applicable. Supplier Qualification Leads local supplier qualifications and re-qualifications; resolves quality issues with local suppliers. Supports QMS assessments for local supplier qualifications and re-qualifications. R&D Division Compliance & Privacy Implements divisional compliance/privacy initiatives locally and supports reporting. Channels compliance/privacy concerns to Local Legal/Compliance/Privacy and to R&D Compliance/Global Privacy Office. Global / Regional Key Initiatives / Projects Supports global/regional key initiatives/projects upon request of the RCQM. Qualifications Bachelor's Degree or equivalent in relevant health care area. A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred. Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations. Solid track record of initiating, planning and delivery of projects and knowledge of project management practices. Demonstrated experience in leading cross-functional teams. Ideally, experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement. Ideally, experience in managing audits and inspections. Ideally, experience in coordinating and delivering training sessions. Skills Excellent project management, organizational and prioritization skills. Excellent teamwork skills, including conflict resolution expertise and discretion. Ability to analyze, interpret, and solve complex problems. Ability to think strategically, objectively and with creativity and innovation. Ability to proficiently interact with all levels of clinical research management and exert influence to achieve results. Required Skills Adaptability Clinical Quality Management Clinical Research Clinical Study Design Clinical Trial Planning Clinical Trials Clinical Trials Monitoring Data Analysis ICH GCP Guidelines Medical Writing Operations Management Patient Safety Process Improvements Project Management Project Prioritization Quality Control Management Quality Management Regulatory Compliance Risk Management Strategic Planning Strategic Thinking Team Leadership Training and Development Employee Status Regular Relocation No relocation VISA Sponsorship No Travel Requirements No Travel Required Flexible Work Arrangements Not Applicable Shift Not Indicated Valid Driving License No Hazardous Material(s) n.a Job Posting End Date 12/3/2025 Requisition ID R Seniority level Not Applicable Employment type Full-time Job function Research, Science, and Health Care Provider Industries Biotechnology Research, Pharmaceutical Manufacturing, and Veterinary Services Referrals increase your chances of interviewing at MSD LATAM by 2x Get notified about new Clinical Specialist jobs in Buenos Aires, Buenos Aires Province, Argentina. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr