Country Clinical Quality Manager (CCQM)

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

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