Country Clinical Quality Manager (CCQM)

Fortrea; São Paulo; Hybrid; BRL 180,000 - 260,000; Full time

Job summary

Fortrea in São Paulo seeks the CCQM to lead clinical quality management locally, ensuring ICH-GCP compliance and adherence to company procedures. You will oversee QA activities, support audits and inspections, CAPA management, and drive continuous improvement across clinical operations.

This role requires a life sciences degree, 6+ years in clinical research or quality, strong communication, and ability to influence cross-functional teams. Hybrid work arrangement; travel up to 15%.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biology, or related healthcare field.
• At least 6 years of experience in clinical research, quality management, or compliance.
• Strong knowledge of ICH-GCP, regulatory requirements and clinical trial processes.

Responsibilities

• Serve as the local quality lead for clinical research activities.
• Ensure compliance with ICH-GCP, regulations, and company procedures.
• Support audits, inspections, CAPA management, and root-cause analysis.
• Coordinate quality control activities and drive continuous improvement.
• Provide guidance on quality and process matters to cross-functional teams.

Skills

Project management

Organizational skills

Problem-solving

Communication skills

English proficiency

Training delivery

Stakeholder influence

Cross-functional work

Education

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biology, or related healthcare field

Job description

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.

At Fortrea, we're all about turning the “impossible” into \"I'm possible\". Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.