Clinical quality assurance - lead

Preferred Skills:

Experience in QMS and ISMS in Clinical Research Organizations and/or pharmaceutical companies with previous experience in system audits and/or inspections by certification bodies Experience in Phase 1 to 4 Clinical Trials Europe and India Awareness of EU Guidelines Handling of inspection and sponsors audit

TECHNICAL / FUNCTIONAL COMPETENCIES:

Quality Management System design & implementation Local and international regulations, guidelines, and standards related to clinical trials, including GCP Audit Process Improvement methodologies e.g., Six Sigma, Lean Training Documentation

Responsibilities:

Quality Management System (QMS) Development:

Provide inputs to Quality Director in enhancing the company's Quality Management System (QMS) and controlled documents related to clinical operations. Develop clear, measurable quality objectives aligned with the organization's strategic goals and regulatory requirements in collaboration with Quality Maintenance Manager (QMM).

Quality Assurance and Audit:

Implement regular internal audits (e.g. site audits, trial specific, data management etc.) and inspections to assess the effectiveness of the QMS and identify areas for improvement. • Perform quality checks and audits of Trial Master File (TMF) documents (both paper and electronic) to ensure completeness and accuracy. Execute regular checks to confirm that clinical trial/study-specific plans are being followed at clinical sites and always achieve audit readiness.

Quality Documentation and Performance Reporting:

Develop clinical trial/study-specific quality metrics to provide insights to Quality Director into study team and site performance. Develop periodic reports detailing compliance and non-compliance trends, identifying potential risks, and presenting findings to the Quality Director. Monitor the external vendor/supplier qualifications and assess their performance by conducting audits.