Director of Quality Assurance and Regulatory Affairs

About UsHawthorne Health is the leading community site network, with 50+ sites across the U.S. and leveraging intelligent technology to accelerate patient access, improve retention, and reduce study costs. By embedding high-quality, compliant research within local communities, Hawthorne makes clinical trials more accessible and convenient for patients.Traditional trial sites are often fragmented and inefficient. Hawthorne streamlines the process by making trials scalable, cost-effective, and patient-centric. By bringing research directly into communities, Hawthorne shortens timelines and helps bring better treatments to market, faster. About the RoleThe Director of Compliance and Regulatory Affairs is responsible for establishing, implementing, and maintaining a robust compliance structure across the Hawthorne Health network. This pivotal role ensures all clinical trials and network operations adhere to local and federal regulations, ICH Good Clinical Practice (GCP) guidelines, and Sponsor requirements. The Director also oversees Hawthorne Health’s regulatory team that is responsible for the accurate and timely management of the networks IRB and regulatory responsibilities.Key Responsibilities1. Quality Management System (QMS) OversightStrategic Leadership: Develop, implement, and continuously improve the network's QMS to ensure clinical operations are standardized, efficient, and fully compliant across all sites.SOP Management: 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.Deviation Management: 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).Internal Audits: 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.Training: Direct the network's compliance training program, ensuring all personnel are appropriately trained on GCP, regulatory requirements, SOPs, and the QMS.2. Regulatory Affairs and ComplianceAudit Management: 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.IRB/EC Management Support: 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.Investigator Site File (ISF) Management: 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.Regulatory Guidance: Provide expert guidance and interpretation of complex federal regulations and international guidelines (ICH-GCP) to network leadership and site staff.3. Strategic and Personnel LeadershipPeople Management: Recruit, mentor, and lead the QA/RA team, fostering a culture of quality, compliance, and continuous improvement.Cross-Functional Collaboration: Partner closely with Operations, Project Management, and Site Leadership to embed quality standards and regulatory compliance into everyday clinical trial execution.Vendor Qualification: Oversee the quality audit and qualification program for critical external vendors utilized by the network.Required QualificationsExperience and EducationBachelor'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.Knowledge, Skills, and AbilitiesSubject 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.Location:This position is remote, with the potential to travel up to 5%. This role operates on East Coast business hours. Candidates located in the Eastern or Central Time Zones are preferred. To find out more about Hawthorne Health, visit: https://hawthornehealth.com