Head of Quality Assurance Job at Cytel - USA & APAC, Cambridge, MA

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  • Cytel - USA & APAC
  • Cambridge, MA

Job Description

RESPONSIBILITIES

  • 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

QUALIFICATIONS

  • 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

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