Quality Assurance Manager

Company Description ClinFocus supports life sciences organizations in accelerating clinical trials and improving data quality through technology-enabled solutions and expert services. The company specializes in EDC development, systems integration, AI deployment, clinical data science, project management, and integrated dashboard development, creating unified and efficient data ecosystems for clinical research. By combining robust technology with experienced clinical data professionals, ClinFocus helps clients enhance trial oversight, streamline operations, and gain deeper, real-time insights. As an ISO-certified organization and accredited Medidata Rave partner, ClinFocus is committed to high quality standards, strong work ethics, and long-term trust-based partnerships. Role Description The Quality Assurance Manager is a full-time remote role responsible for overseeing and improving quality processes across ClinFocuss clinical and technology services. This position manages the development, implementation, and maintenance of QA frameworks, SOPs, and compliance documentation aligned with industry regulations and ISO standards. Day-to-day activities include planning and conducting internal and supplier audits, monitoring quality metrics, investigating and documenting deviations, and driving corrective and preventive actions. The Quality Assurance Manager collaborates closely with project management, clinical data, and technology teams to ensure consistent delivery quality, supports training on QA procedures, and contributes to continuous improvement initiatives across the organization. Qualifications Experience in quality management, including development and maintenance of QA systems, SOPs, and compliance frameworks in life sciences or clinical research environments. Strong skills in audit planning and execution, deviation and CAPA management, and risk assessment for technology-enabled clinical solutions. Knowledge of relevant regulations and standards (e.g., GCP, ICH guidelines, ISO standards, data integrity principles, and computer system validation best practices). Ability to work cross-functionally with project management, clinical data science, and technology teams to align quality practices with operational needs. Proficiency in using quality and documentation tools, and in analyzing quality metrics to identify trends and improvement opportunities. Excellent written and verbal communication skills, with the ability to prepare clear reports, procedures, and training materials. Strong organizational and time-management abilities, with attention to detail and the capacity to manage multiple concurrent projects remotely. Bachelors degree in Life Sciences, Quality Management, Engineering, or a related field; advanced degree or relevant certifications (e.g., in QA, auditing, or regulatory compliance) are an advantage. .