Director of Quality Assurance. Richmond LilyLifestyle

Join Cytel as the Director of Quality Assurance and play a pivotal role in shaping our global Quality Assurance strategy to align with our business growth and regulatory demands.

• Lead the evolution of Cytel's global Quality Assurance strategy, ensuring it meets both business growth and regulatory standards.
• Oversee, maintain, and continuously enhance our Quality Management System (QMS) to ensure optimal performance.
• Serve as a senior leader during sponsor audits and regulatory inspections, showcasing your expertise and leadership.
• Drive the modernization of Quality Assurance through the adoption of digital tools, automation, and AI-enabled solutions.
• Enhance consistency and reduce variability in audit readiness, execution, and responses across the organization.
• Collaborate closely with operational and functional teams to embed quality practices into daily operations.
• Streamline QA processes to alleviate unnecessary burdens while maintaining robust compliance with applicable regulations.
• Build, mentor, and develop a high-performing global QA team, fostering a culture of excellence.

• Implementing automated audit management and response-tracking systems to enhance efficiency.
• Leveraging AI-assisted tools for document review, SOP lifecycle management, and audit preparation.
• Applying data analytics to identify quality trends, risks, and potential early-warning signals.
• Streamlining CAPA management through workflow automation to improve responsiveness.
• Enhancing dashboards and reporting to provide real-time insights into quality metrics.

• 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 successfully.
• Demonstrated success in modernizing QA processes and systems.
• Experience utilizing technology, automation, or AI to enhance quality systems is preferred, focusing on practical and effective solutions.
• Strong business acumen with the ability to influence and collaborate effectively with senior stakeholders.

• Be part of a foundational team that positions Quality as a competitive advantage for our organization.
• Engage in a high-impact leadership role with visibility across the company and among clients.
• Experience a collaborative environment with highly skilled operational teams.
• Make a meaningful impact by shaping a modern, scalable, technology-enabled quality function.

Cytel Inc. is an Equal Employment / Affinitive Action Employer. We consider applicants for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.