Develop, implement, and continuously improve the network's QMS to ensure clinical operations are standardized, efficient, and fully compliant across all sites.
Oversee the development, revision, review, and controlled distribution of all Standard Operating Procedures (SOPs), work instructions, and quality documents. Ensure all documents reflect current regulations and best practices.
Design and manage the network-wide system for tracking, reviewing, classifying, and resolving protocol deviations and violations. Analyze deviation trends to identify systemic issues and implement corrective and preventive actions (CAPAs).
Establish and lead an internal audit program to assess the ongoing compliance of network sites and processes. Report findings and monitor the effectiveness of subsequent CAPAs.
Direct the network's compliance training program, ensuring all personnel are appropriately trained on GCP, regulatory requirements, SOPs, and the QMS.
Serve as the primary network point-of-contact and lead for all external audits, including those conducted by Sponsors, Contract Research Organizations (CROs), and Regulatory Agencies (e.g., FDA). Manage the preparation, conduct, and follow-up/response for all inspection activities.
Oversee and standardize the process for site-level submissions to Institutional Review Boards (IRBs) and Ethics Committees (ECs), ensuring rapid turnaround and compliance with study protocols and regulatory requirements.
Establish the standard for and oversee the centralized management of the Investigator Site File/Site Trial Master File (STMF) across the network, ensuring documentation is current, complete, and inspection-ready at all times.
Provide expert guidance and interpretation of complex federal regulations and international guidelines (ICH-GCP) to network leadership and site staff.
Recruit, mentor, and lead the QA/RA team, fostering a culture of quality, compliance, and continuous improvement.
Partner closely with Operations, Project Management, and Site Leadership to embed quality standards and regulatory compliance into everyday clinical trial execution.
Oversee the quality audit and qualification program for critical external vendors utilized by the network.

Requirements

Bachelor's degree in a life science, healthcare, or related field;
Minimum of 4+ years of progressive experience in Quality Assurance and/or Regulatory Affairs within a clinical research environment (Site Network, CRO, or Sponsor).
Demonstrated expertise in interpreting and applying ICH-GCP, FDA regulations (e.g., 21 CFR), and other global clinical trial regulations.
Subject Matter Expertise: Deep, practical knowledge of QMS principles, risk-based quality approaches, and regulatory inspection readiness.
Leadership and Communication: Exceptional leadership presence and the ability to effectively communicate complex regulatory and quality information to both technical teams and executive leadership.
Analytical Skills: Proven ability to perform root cause analysis, design effective CAPAs, and drive sustainable process improvements.
Professional Certification: Relevant certification (e.g., RQAP-GCP, RAC) highly desirable.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

Quality Management System (QMS)Standard Operating Procedures (SOPs)Corrective and Preventive Actions (CAPAs)Root Cause AnalysisRegulatory ComplianceClinical Trial RegulationsRisk-Based Quality ApproachesInspection ReadinessProtocol Deviations ManagementQuality Audit

Soft skills

LeadershipCommunicationAnalytical SkillsMentoringCollaborationContinuous ImprovementProblem SolvingInterpersonal SkillsTrainingTeam Management

Certifications

RQAP-GCPRAC