Clinical Quality Senior Manager Brazil

Overview It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Clinical Quality Senior Manager Brazil (CCQM) oversees all CQM activities in the country/cluster under the guidance of the Regional Director, Clinical Quality Management (RCQM). The role involves implementing local/global processes and procedures, identifying opportunities for process improvement, and supporting continuous improvement initiatives. The CCQMs support audits, inspections as well as Quality Control and local training activities. In this role you will be responsible Regulations & Processes Local expert for ICH-GCP and local regulations (including impact assessment of new/updated local regulations on local processes). Collaborate with local country operations management to manage the local network of owners/Subject Matter Experts (SMEs) for global/local processes to ensure proper implementation of processes and regular updates of local Standard Operating Procedures (SOPs) / Work Instructions (WIs). Local expert for any quality-related local processes. Identify process gaps / opportunities for process improvement and escalate to RCQM and/or Global Process Owners (if necessary). Lead continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM; support or co-lead continuous improvements at global/regional level. Training Local training point of contact and liaison between local country operations and Learning & Development (L&D). Identify / coordinate local training needs in collaboration with local country operations management. Support local trainings as needed. Quality Control (QC) Activities Coordinate and oversee all QC activities with local country operations management, ensuring proper execution of the In-house Quality Control Plan (IHQCP), Quality Control Visits (QCVs) and other QC checks. In agreement with local country operations management and RCQM, perform QC activities (incl. QCVs) and conduct ad hoc site visits upon request. Identify local trends, perform root-cause analysis if necessary, and develop local action plans including sharing results and training of local country operations, if required. Audits & Inspections Primary local point of contact for Company Research Lsbs, Quality Assurance and Regulatory Agencies. Manage and support activities during the preparation / ongoing / follow-up phases of audits or inspections. Perform root-cause analysis for audit observations/inspection findings in cooperation with local operations and/or headquarters; manage CAPAs and coordinate responses to audit/inspection reports. Identify local trends, perform root-cause analysis as needed, and develop local action plans including sharing results and training of local operations, if required. Quality / Compliance / Privacy Issue Escalation Communicate/escalate quality/compliance issues (including potential trends) to local country operations management and RCQM. Escalate significant quality/compliance issues and support investigations (fact finding, root-cause analysis) and reporting of Serious Breaches, if applicable. Serve as local point of contact or support local POC in case of escalations/reporting of Privacy Incidents, if applicable. Clinical Supplies GCP Investigations Evaluate trends on Clinical Supply GCP inquiries and incorrect management of clinical supplies. Coordinate GCP investigations of trends related to Clinical Supply GCP inquiries and improper management of clinical supplies (as needed). Supplier Qualification Lead local supplier qualifications and re-qualifications of locally selected suppliers; support solving of quality issues with these suppliers. Support the Quality Management System (QMS) assessment for local supplier qualifications and re-qualifications. Compliance & Privacy Steward Support implementation of divisional compliance/privacy initiatives and reporting at the local level. Communicate compliance/privacy concerns to local legal/compliance/privacy department and/or Compliance/Global Privacy Office. Global / Regional Initiatives / Projects Support global/regional key initiatives/projects upon request of the RCQM. Qualifications & Experience Bachelor's Degree or equivalent in a relevant health care area. 6-8 years of relevant experience in clinical research including direct field monitoring or management/oversight of such individuals, with a proven record of accomplishment. Country Operations experience is preferred. Deep knowledge of Clinical Trial processes, GCP and related regulations. Solid track record in initiating, planning and delivering projects; 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 Superior oral and written communication and leadership skills in an international environment. Excellent project management, organizational and prioritization skills. Excellent teamwork skills, including conflict resolution and discretion; ability to analyze, interpret, and solve complex problems. Strategic thinking, objectivity, creativity and innovation. Ability to interact effectively with all levels of clinical research management and influence results. Required Skills Adaptability, Clinical Quality Assurance, Clinical Quality Management, Clinical Research, Clinical Study Design, Clinical Systems Implementation, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Conflict Resolution, Data Analysis, Global Initiatives, ICH GCP Guidelines, Medical Research, Medical Writing, Patient Safety, Process Improvements, Project Prioritization, Quality Control Management, Regulatory Compliance, Risk Management, Strategic Planning, Strategic Thinking, Team Leadership, Training and Development Notes Relocation not specified; VISA Sponsorship not specified; Travel Requirements not specified; Preferred Skills indicate general guidance for current employees and contingent workers; Job Posting End Date 10/28/2025 #J-18808-Ljbffr