Head of Quality Assurance
Job
Cytel
Indianapolis, IN (In Person)
Full-Time
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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 functionCytel Inc.
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