Director of Quality and Regulatory Affairs at Hawthorne Health

Strong clinical research depends on trust, accuracy and compliance. Every site, every document and every process must follow strict rules to protect patients and deliver reliable data. Hawthorne Health is looking for a leader who can guide these standards across a wide network of community based research sites.

Hawthorne Health operates more than fifty sites across the United States. Their approach brings clinical trials closer to patients by placing research directly inside local communities. This model removes common barriers, improves access and helps new treatments reach the market faster. The company uses smart technology and strong operational systems to support sponsors, reduce delays and keep studies on track.

Job Summary

Position: Director of Quality and Regulatory Affairs
Company: Hawthorne Health
Location: Remote, United States
Employment: Full time
Salary Range: 130,000 to 160,000 per year
Job Category: Quality assurance and regulatory affairs

About the Company

Hawthorne Health is reshaping how clinical trials operate. Traditional sites often struggle with slow processes, uneven performance and gaps in patient support. Hawthorne solves these problems by creating a scalable site network supported by standard systems and advanced tools. Their work improves patient access and speeds up study timelines.

The team focuses on quality, compliance and patient experience. They work with sponsors to deliver accurate results while helping communities take part in meaningful research. The company continues to grow and now needs a senior leader who can oversee the full quality and regulatory framework that supports the network.

About the Role

The Director of Quality and Regulatory Affairs builds and manages the full compliance structure for the site network. You guide the development of the Quality Management System. You lead the regulatory team that handles IRB submissions and key documents. You ensure all teams follow ICH-GCP, FDA regulations and sponsor requirements.

This role shapes how quality standards are applied across the entire network. You develop systems that identify risks early. You guide corrective actions and make sure problems do not repeat. You also support internal teams through training, audits and documentation. Your work strengthens trust with sponsors and prepares the network for growth.

What You Will Do

You design and improve the Quality Management System. You create or update standard procedures, work instructions and quality records. You ensure documents reflect current regulations and best practices. You also establish systems that track deviations across sites. You review trends and guide corrective actions to prevent future issues.

You lead an internal audit program. You evaluate site performance and document the results. You guide teams as they complete corrective actions. You manage compliance training for all network staff. You ensure they understand regulations, quality standards and the expectations of the QMS.

You manage external audits. You serve as the main point of contact for sponsors, CRO teams and regulatory agencies. You guide preparation, support site teams during audits and oversee the response process. You ensure all follow up actions are completed correctly.

You oversee IRB and ethics committee submissions. You improve processes so that documents move quickly and meet study requirements. You also lead the standards for the Investigator Site File and Trial Master File. You ensure documents are inspection-ready at all times.

You guide regulatory interpretation. You help leadership understand new regulations and how they apply to clinical operations. You support risk based planning and make sure the company stays prepared for any changes in requirements.

You lead the quality and regulatory team. You recruit, mentor and guide staff. You build a culture that values accuracy, transparency and continuous improvement.

You work closely with operations, project management and site leadership. You help embed quality into daily work. You support vendor qualification by guiding audits and confirming that critical partners meet the network’s standards.

What You Bring

You have a bachelor’s degree in a life science, healthcare field or related area. You have at least four years of experience in quality assurance or regulatory affairs within clinical research. You know how to apply ICH-GCP, FDA rules and other global regulations. You understand QMS principles and inspection readiness.

You have strong leadership skills. You communicate complex information in simple terms. You guide teams through problem solving and build clear processes. You know how to perform root cause analysis and design corrective actions that work. You may also hold a certification in quality or regulatory affairs.

Why This Role Matters

Clinical studies must meet strict requirements to protect patients and deliver credible results. Your work ensures the network stays compliant, efficient and ready for growth. You help create a strong quality culture that supports both current trials and future expansion. Your leadership improves processes, reduces risk and strengthens the company’s ability to run high quality research at scale.

Location and Schedule

This role is remote. It may require up to five percent travel. The team works on Eastern Time, and candidates in Eastern or Central Time are preferred.