Head of Quality Assurance

Cytel is seeking a Head of Quality Assurance to lead and further strengthen our global quality function. This role builds on a solid existing foundation and focuses on enhancing scalability, consistency, and effectiveness of quality systems to support Cytel’s continued growth as a global CRO.

This leader will play a pivotal role in advancing a modern, technology-enabled QA organization. The position emphasizes practical use of automation, digital tools, and AI-enabled solutions to improve efficiency, consistency, and insight generation—while maintaining the highest standards of regulatory compliance.

• 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

• 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 Quality Assurance within a CRO, pharmaceutical, or biotechnology environment
• Strong expertise in GxP regulations and audit/inspection processes
• Proven experience leading sponsor audits and regulatory interactions
• Demonstrated success in improving and modernizing QA processes
• Experience leveraging technology, automation, or AI to enhance quality systems strongly preferred, with an emphasis on practical, fit-for-purpose solutions rather than large-scale transformation initiatives
• Strong business acumen and the ability to influence and partner effectively with senior stakeholders

• Opportunity to build on a strong foundation and position Quality as a competitive advantage
• High-impact leadership role with visibility across the organization and with clients
• Collaborative environment with deeply experienced operational teams
• Meaningful opportunity to shape a modern, scalable, technology-enabled quality function