Country Clinical Quality Manager (CCQM)

Fortrea · São Paulo, São Paulo, Brazil

**Job Overview** * 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, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities. **Summary Of Responsibilities** * Serve as the local quality lead for clinical research activities, ensuring compliance with ICH\-GCP, applicable regulations, and company procedures. * Support and lead audit and inspection readiness activities, including CAPA management, root cause analysis, and corrective action follow\-up. * Coordinate quality control activities, identify trends, and drive continuous improvement initiatives across clinical operations. * Provide guidance on quality, compliance, and process\-related matters to cross\-functional teams and stakeholders. * Support the implementation and maintenance of SOPs, training programs, and quality management processes. * Partner with clinical operations teams to promote a culture of quality and ensure ongoing regulatory compliance. * Participate in risk assessments, investigations, and quality oversight activities to support the successful execution of clinical trials **Qualifications (Minimum Required)** * Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biology, or a related healthcare field. * 6\+ years of experience in clinical research, clinical operations, quality management, compliance, or related functions. * Strong knowledge of ICH\-GCP, regulatory requirements, and clinical trial processes. * Experience supporting audits, inspections, CAPA management, root cause analysis, and quality improvement initiatives. * Experience working in cross\-functional and matrix organizations. * Strong project management, organizational, and problem\-solving skills. * Excellent verbal and written communication skills, with the ability to influence stakeholders at all levels. * Experience delivering training, implementing processes, and driving continuous improvement activities. * Previous experience in clinical quality, compliance, inspections, audits, or quality oversight activities is highly desirable. * Advanced English proficiency. **Physical Demands/Work Environment** * Availability for hybrid model (3x a week in sponsor's office in Sao Paulo) * Travel Requirements: * Available for travel up to 15% of the time including overnight stays as necessary consistent with project needs and office location Learn more about our EEO \& Accommodations request here.