Hiring: Quality & Compliance Manager (Clinical Trials & QMS)
Company: Hawthorne Health
Location: United States (Remote / Hybrid)
Employment Type: Full-time
Seniority Level: Mid-Senior level
Estimated Salary: $85,000 - $110,000 per year
Industry: Biotechnology / Clinical Research / Pharmaceuticals
Company Overview
Hawthorne Health stands out as a leading community trial site network and provider of decentralized home research visit solutions, with more than 20 clinical sites and over 2,000 research-experienced healthcare professionals across the United States.
Hawthorne Health uses accessible community locations, structured patient data ecosystems, and advanced healthcare technology to bring top-tier clinical research into local communities.
This approach speeds up patient access, improves trial retention, cuts operational study costs, and safely brings crucial medical treatments to the market faster.
Key Responsibilities
QMS Administration & Maintenance: Take charge of the daily operations for the organization's Quality Management System (QMS). Stay on top of document control, training based on specific roles, internal protocol deviations, particular quality events, and Corrective and Preventive Actions (CAPAs), keeping everything tightly tracked and monitored.
SOP Framework & Document Control: Organize cross-functional reviews, get executive approvals, and handle regular updates of corporate Standard Operating Procedures (SOPs) and clinical work instructions. Manage version control, status logs, and control who can access each document.
Internal Auditing & Monitoring Alignment: Set up and carry out regular internal audits, quality checks focused on specific studies, and targeted for-cause reviews. Write detailed audit reports, resolve all system findings, and review incoming monitoring logs from CROs or sponsors to spot and address risks.
Deviation & CAPA Infrastructure: Review and classify all reports of protocol deviations and data violations. Lead thorough root cause analyses, create actionable CAPA plans, check supporting documentation, and maintain up-to-date quality metric trackers.
External Inspection Readiness: Build audit tracking files, gather requested data evidence, and coordinate documentation from different teams when regulatory agencies, sponsors, or CROs come to audit.
Operational Quality Reviews: Conduct high-level quality control and inspection-readiness checks throughout crucial study document archives, like Informed Consent Forms (ICFs), raw source documents, Investigator Site Files (ISFs), and regulatory binders, to make sure everything complies with protocols, company SOPs, FDA rules, and ICH-GCP requirements.
Experience & Qualifications
4-7 years of experience managing quality compliance systems, running clinical trial operations, or working with site management networks in a highly regulated health environment.
Hands-on experience working with and improving dedicated Quality Management Systems (QMS) and secure document control tools.
A solid track record handling complex validation processes for protocol deviations, doing deep root cause analyses, and managing the entire CAPA life cycle.
Proven success working across multiple clinical teams, including Clinical Operations, Regulatory Affairs, Project Managers, and executive Site Leaders.
Strong commitment to maintaining clinical data integrity, patient confidentiality, and thorough record-keeping.
Technical Skills Required
Regulatory Frameworks: Deep expertise in ICH Good Clinical Practice (GCP) guidelines, FDA 21 CFR Part 11, and Institutional Review Board (IRB) protocols.
Systems & Tools: Solid familiarity with automated QMS platforms, electronic Document Management Systems (eDMS), Electronic Data Capture (EDC) systems, and electronic Trial Master Files (eTMF).
Analytics & Reporting: Advanced skills tracking quality metrics, analyzing systemic error trends, and preparing compliance reporting for board review.
How to Apply
If you’re interested in this Quality and Compliance leadership role, please send your resume, clinical trial operations portfolio, and compliance background through the Hawthorne Health recruitment network.