The Head of Quality Assurance will lead Cytel's global QA strategy, enhance the Quality Management System, and drive modernization through digital tools and automation. Responsibilities include managing audits, compliance, and mentoring a high-performing QA team.
Responsibilities
Qualifications
- 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
Cytel Waltham, Massachusetts, USA Office
1050 Winter Street, Suite 2700, Waltham, MA, United States, 02451
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