Cytel

Head of Quality Assurance

Cytel  •  United States (Onsite)  •  25 days ago
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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 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
Cytel

About Cytel

Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.

Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Cambridge, MA
Year Founded
1987
Website
cytel.com
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