Quality Specialist- Research

Company Overview

Aton Health is a clinician-first clinical research company rethinking how evidence is generated in modern healthcare. Instead of treating trials as separate from care, we embed research directly into real-world clinical workflows, helping sponsors and specialty practices accelerate enrollment, improve study execution, and generate high-quality, audit-ready evidence at scale. Our model depends on operational precision and regulatory rigor. We’re building a team that takes pride in running studies the right way and where compliance isn’t a checkpoint, but a standard embedded in every aspect of execution.

Position Summary

We 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 provides independent oversight of operational processes to ensure adherence to regulatory requirements, sponsor expectations, and internal policies. The Manager will lead internal audits, vendor qualification, inspection readiness efforts, and continuous quality improvement initiatives.

This position reports to the Director, Quality and Compliance and operates independently from Clinical Operations.

Key Responsibilities

1. Quality Management System (QMS) Oversight

• Own and maintain the company’s QMS framework
• Manage SOP lifecycle (authoring, review, approval, version control)
• Lead change control and document control processes
• Oversee CAPA tracking and effectiveness checks
• Apply risk-based approaches within quality management activities
• Maintain training matrix and compliance tracking

2. GCP & Regulatory Compliance

• Ensure adherence to ICH E6 guidelines issued by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
• Maintain compliance with applicable FDA regulations applicable
• Assess informed consent and enrollment documentation through audits and quality reviews.
• Stay current on GCP expectations and apply relevant updates to quality processes.

3. Audit & Inspection Readiness

• Develop and execute internal audit program
• Conduct process, vendor, and study-level audits
• Prepare organization for sponsor audits and regulatory inspections
• Lead response to audit findings
• Develop and track CAPAs to closure
• Conduct mock inspections and readiness assessments

4. Vendor Qualification & Oversight

• Support vendor qualification activities through quality assessments and documentation review
• Perform due diligence assessments
• Maintain vendor files and requalification schedules
• Monitor vendor performance and compliance documentation

5. Training & Quality Culture

• Develop GCP and compliance training programs
• Ensure employee training completion and documentation
• Partner with department leads to embed quality into operational workflows
• Promote continuous improvement initiatives

Qualifications

Required

• Bachelor’s degree in life sciences, healthcare, or related field
• 5 years of experience in clinical research quality, QA, or compliance
• Direct experience with GCP auditing
• Experience building or maintaining a QMS
• Working knowledge of FDA regulations and ICH GCP
• Strong documentation and technical writing skills

Preferred

• Experience in a CRO or enrollment-focused research organization
• Experience preparing for sponsor or regulatory inspections
• Familiarity with electronic QMS or document management systems
• Certification in Quality (e.g., CQA, RAC) preferred

Competencies

• Independent judgment and integrity
• Ability to influence without direct authority
• Strong attention to detail
• Risk-based decision making
• Operational pragmatism (balances compliance with business needs)
• Strong written and verbal communication skills

Success Metrics (First 12 Months)

• QMS fully documented and inspection-ready
• Internal audit program established
• Zero critical audit findings
• Vendor qualification framework implemented
• 95% training compliance
• CAPA program operational with documented effectiveness reviews

Work Environment

• Small, growth-stage organization
• Hands-on role with strategic and tactical responsibilities
• High visibility with executive leadership
• Opportunity to shape quality infrastructure from the ground up

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee must occasionally lift and or move up to 10 pounds. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

AAP/EEO Statement

The Company is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. The Company prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. The Company conforms to the spirit as well as to the letter of all applicable laws and regulations.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Pay: From $80,000.00 per year

Benefits:

• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Work Location: Hybrid remote in Kansas City, MO 64114

Salary : $80,000