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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