Quality Manager- Clinical Research

Must be able to communte to our Kansas City office. About Aton HealthAton Health is a clinician-first clinical research company redefining how evidence is generated in modern healthcare. Rather than treating clinical trials as separate from care delivery, we embed research directly into real-world clinical workflows.Our approach enables sponsors and specialty practices to accelerate enrollment, improve study execution, and generate high-quality, audit-ready evidence at scale. We operate with a strong emphasis on operational precision and regulatory rigor—where quality and compliance are built into every step, not treated as an afterthought.We’re looking for team members who take pride in doing things the right way and want to help raise the standard for clinical research execution.About the RoleWe are seeking a Quality Manager to lead and maintain Aton Health’s Quality Management System (QMS) and ensure compliance with Good Clinical Practice (GCP) and applicable regulatory requirements. We’ve built this position to support learning and development. If you have a solid foundation and are eager to grow, we’ll provide the training and support to help you succeed.This role plays a critical part in maintaining audit readiness, supporting continuous improvement, and providing independent oversight of operational processes within our decentralized research model.You’ll work cross-functionally while maintaining independence from Clinical Operations and will report directly to the Director of Quality & Compliance.What You’ll DoQuality Management System (QMS)Own and manage the company’s QMS frameworkOversee the full SOP lifecycle (authoring, review, approval, version control)Lead document control and change control processesManage CAPA tracking, investigations, and effectiveness checksApply risk-based quality management principlesMaintain training matrix and compliance tracking systemsGCP & Regulatory ComplianceEnsure compliance with ICH E6 GCP guidelines and FDA regulationsConduct quality reviews of informed consent and enrollment documentationStay current on regulatory updates and implement process improvementsServe as a subject matter expert on GCP and compliance standardsAudit & Inspection ReadinessDevelop and execute internal audit programsConduct process, vendor, and study-level auditsPrepare teams for sponsor audits and regulatory inspectionsLead audit responses and CAPA development through closureConduct mock inspections and readiness assessmentsVendor OversightSupport vendor qualification and due diligence activitiesMaintain vendor documentation and requalification schedulesMonitor vendor performance and complianceTraining & Quality CultureDevelop and deliver GCP and compliance training programsEnsure training completion and documentation across the organizationPartner with teams to embed quality into daily workflowsDrive continuous improvement initiativesRequired QualificationsBachelor’s degree in life sciences, healthcare, or related field3+ years of experience in clinical research, QA, or complianceFamiliarity with GCP auditingStrong knowledge of FDA regulations and ICH GCP guidelinesExcellent documentation and technical writing skillsPreferred QualificationsExperience in a CRO or enrollment-focused research organizationExperience supporting sponsor audits or regulatory inspectionsFamiliarity with electronic QMS or document management systemsProfessional certification (e.g., CQA, RAC)Why Join Aton Health?Be part of a company reshaping how clinical research is conductedWork in a high-impact role with real ownership and autonomyCollaborate with a team that prioritizes quality, rigor, and innovationHelp build scalable systems that improve research and patient care