ShortDescriptionStr
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.
- 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
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Why Join Cytel
- 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
InternalQualificationsStr
- 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
-
Why Join Cytel
- 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
InternalResponsibilitiesStr
- 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
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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
-
ExternalResponsibilitiesStr
- 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
