Head of Quality Assurance
ResponsibilitiesLead and evolve Cytel's global Quality Assurance strategy in alignment with business growth and regulatory expectationsOversee, maintain, and continuously enhance the Quality Management System (QMS)Serve as a senior leader during sponsor audits and regulatory inspectionsDrive modernization of QA through adoption of digital tools, automation, and AI-enabled solutionsImprove consistency and reduce variability in audit readiness, execution, and responsesPartner closely with operational and functional teams to embed quality into day-to-day executionStreamline QA processes to reduce unnecessary burden while maintaining robust complianceBuild, mentor, and develop a high-performing global QA teamExamples of modernization, automation, and AI and qualificationsImplementing automated audit management and response-tracking systemsLeveraging AI-assisted tools for document review, SOP lifecycle management, or audit preparationApplying data analytics to identify quality trends, risks, and early-warning signalsStreamlining CAPA management through workflow automationEnhancing dashboards and reporting to provide real-time quality insightsSignificant experience in Quality Assurance within a CRO, pharmaceutical, or biotechnology environmentStrong expertise in GxP regulations and audit/inspection processesProven experience leading sponsor audits and regulatory interactionsDemonstrated success in improving and modernizing QA processesExperience 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 initiativesStrong business acumen and the ability to influence and partner effectively with senior stakeholdersWhy Join CytelOpportunity to build on a strong foundation and position Quality as a competitive advantageHigh-impact leadership role with visibility across the organization and with clientsCollaborative environment with deeply experienced operational teamsMeaningful opportunity to shape a modern, scalable, technology-enabled quality functionCytel Inc. is an Equal Employment / Affimative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.J-18808-Ljbffr