Clinical Quality Assurance Manager

Key Responsibilities:

1. Quality Management System (QMS) Development

• Support the Quality Director in the development, enhancement, and maintenance of the organization's Quality Management System (QMS) and controlled documents related to clinical operations.
• Collaborate with the Quality Maintenance Manager (QMM) to establish clear, measurable quality objectives aligned with organizational goals, regulatory requirements, and industry standards.
• Promote the effective communication and implementation of quality objectives across all levels of the organization to foster a strong quality culture.
• Design and deliver quality-related training programs to increase awareness, understanding, and adherence to quality standards, regulations, and best practices.

2. Quality Assurance, Compliance, and Auditing

• Plan, conduct, and manage internal audits and inspections (e.g., site audits, trial-specific audits, data management audits) to evaluate QMS effectiveness and identify improvement opportunities.
• Perform quality reviews and audits of Trial Master File (TMF) documentation, including both paper-based and electronic records, to ensure completeness, accuracy, and regulatory compliance.
• Conduct routine compliance checks to verify adherence to clinical trial/study-specific plans, protocols, sponsor requirements, and regulatory standards, ensuring continuous audit readiness.
• Prepare comprehensive audit reports identifying compliance gaps, process deficiencies, and areas of risk, while recommending appropriate corrective and preventive actions (CAPAs).
• Provide guidance and consultation on applicable regulations, guidelines, and industry standards governing clinical research and clinical trials.

3. Quality Documentation and Performance Reporting

• Develop and monitor study-specific quality metrics and key performance indicators (KPIs) to assess study team and site performance, providing actionable insights to the Quality Director.
• Prepare periodic compliance and quality reports highlighting trends, risks, non-compliance observations, and improvement opportunities.
• Evaluate and monitor the qualification, compliance status, and performance of external vendors and suppliers through assessments and audits.
• Review clinical trial documentation, including protocols, reports, protocol deviations, CAPAs, and related records, to ensure accuracy, completeness, and compliance with regulatory requirements.

4. Policies, Procedures, and Continuous Improvement

• Execute day-to-day quality activities in accordance with applicable policies, processes, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), study protocols, sponsor requirements, and regulatory guidelines.
• Stay informed of emerging industry trends, regulatory updates, and best practices in quality management, contributing to the continuous improvement of systems, processes, and procedures.
• Ensure full compliance with the organization's Quality Management System (QMS), Information Security Management System (ISMS), data protection regulations, and other relevant national and international legislative requirements.
• Develop, update, review, and maintain clinical quality documents, including SOPs, work instructions, guidelines, templates, and other controlled documentation to support quality and compliance objectives.