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.