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

Job Tags

Permanent employment

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

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