Quality Manager

Headlands Research

Quality Manager ensuring compliant clinical trial operations across Headlands Research’s US clinical-site network. Developing SOPs, auditing studies, managing CAPAs, assessing risks, and supporting training and acquisitions.

Posted 8/14/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in creating and maintaining Standard Operating Procedures (SOPs) and ensuring compliance with ICH-GCP regulations. Proficient in conducting quality reviews, developing training materials, and implementing corrective actions to enhance operational efficiency.

Highest-signal resume keywords

Clinical Research ExperienceICH-GCP ComplianceSOP DevelopmentCAPA ImplementationRegulatory Reporting

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Standard Operating Procedures (SOPs)Regulatory ComplianceQuality ReviewsCAPA PlansRisk AssessmentTraining DevelopmentClinical Research RegulationsCGXP KnowledgeReport PreparationInternal Audits

Soft Skills

Attention to DetailEffective CommunicationOrganizational SkillsTeam CollaborationAutonomous Work

Tools & Technologies

MS Office

Certifications & Qualifications

Clinical Research Certification

Industry Keywords

Clinical ResearchICH-GCPRegulatory ComplianceQuality AssuranceSite Inspection Readiness

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Create and maintain Standard Operating Procedures (SOPs), Work Instructions, and other network- and site-level guidance
Review and edit SOPs and work instructions for regulatory compliance and conformity to network SOPs
Support development and delivery of network and site-level training events
Conduct internal study reviews for compliance with ICH-GCP and applicable regulations
Prepare reports on study review activities, categorize findings by risk, and propose corrective actions
Work with operations teams to remediate issues and noncompliance and implement preventive actions
Participate in quality investigations
Assist site operations with developing, implementing, and tracking CAPA plans
Assess and report site risks to operations
Conduct and report quality reviews of external sites for M&A due diligence
Participate in integrating acquired sites into the network
Share best practices to maintain site inspection readiness
Attend external audits and update internal leadership
Track and assist required employee training
Support development and delivery of training materials for site employees
Help site directors assess employee performance against quality standards
Participate in continuing education opportunities
Travel up to 30% domestically and/or internationally

Requirements

What you’ll need

5+ years of experience in the clinical research industry required
Certification by a professional clinical research organization preferred
Bachelor’s degree or equivalent required
Associate’s degree with 5 years of equivalent experience will be considered
Excellent knowledge of current federal and local clinical research regulations and GCP
Skills adaptable from other cGXP work environments
Comfortable traveling up to 30% domestically or internationally, including Canada
Extreme attention to detail
Ability to communicate and work effectively with a diverse team of professionals
Strong communication and organizational skills
Comfortable taking direction from a supervisor or working autonomously
Proficient computer skills and use of MS Office
Ability to build rapport with employees and external clients

Benefits

Comp & perks

Equal Opportunity Employer
Reasonable accommodation in employment and the application process for individuals with disabilities
Continuing education opportunities to stay up to date on relevant quality initiatives, regulatory guidance, and industry best practices