Head of Quality Assurance
Cytel · US
- Lead and evolve Cytel’s global Quality Assurance strategy in alignment with business growth and regulatory expectations - Oversee, maintain, and continuous...
Job description
- Lead and evolve Cytel’s global Quality Assurance strategy in alignment with business growth and regulatory expectations - Oversee, maintain, and continuously enhance the Quality Management System (QMS) - Serve as a senior leader during sponsor audits and regulatory inspections - Drive modernization of QA through adoption of digital tools, automation, and AI-enabled solutions - Improve consistency and reduce variability in audit readiness, execution, and responses - Partner closely with operational and functional teams to embed quality into day-to-day execution - Streamline QA processes to reduce unnecessary burden while maintaining robust compliance - Build, mentor, and develop a high-performing global QA team Examples of modernization, automation, and AI may include: - Implementing automated audit management and response-tracking systems - Leveraging AI-assisted tools for document review, SOP lifecycle management, or audit preparation - Applying data analytics to identify quality trends, risks, and early-warning signals - Streamlining CAPA management through workflow automation - Enhancing dashboards and reporting to provide real-time quality insights - Significant experience in...