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Hawthorne Health, Inc. · 18 hours ago

Director of Quality and Regulatory Affairs

United States

Full-time

Remote

Lead/Staff, Director/Executive

$130K/yr - $160K/yr

4+ years exp

Hawthorne Health is the leading community site network, leveraging intelligent technology to improve patient access and streamline clinical trials. The Director of Quality and Regulatory Affairs will establish and maintain a compliance structure across the network, ensuring adherence to regulations and overseeing the regulatory team.

Clinical TrialsHealth CareInformation Technology

Responsibilities

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

Qualification

Quality Management System (QMS)ICH-GCP expertiseRegulatory AffairsRoot Cause AnalysisProfessional CertificationAnalytical SkillsLeadershipCommunication

Required

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