Quality Systems Specialist - Legal; Risk & Compliance

About Signant Health

At Signant Health, we help bring life-changing treatments to patients faster. We are a global evidence generation company that supports clinical trials with smart technology, scientific expertise, and hands-on operational support — so better data leads to better decisions in healthcare. We embrace AI and advanced technologies to enhance every aspect of what we do, from data analysis to operational efficiency.

Our teams work at the intersection of science, technology, and patient experience, delivering digital solutions powered by AI innovation that make clinical trials more efficient, more accurate, and more accessible around the world. Trusted by leading pharmaceutical companies and CROs, our platforms and services support studies across more than 90 countries and have contributed to hundreds of new drug approvals. 

If you are motivated by meaningful work, global impact, and innovation in clinical research and digital health — including the opportunity to work with cutting-edge AI technologies — you will find purpose and opportunity at Signant Health.

About the Role

 This position combines Quality Management System (QMS) administration, document control, training coordination, and metrics responsibilities. The ideal candidate will help maintain and optimize the QMS platform and related systems, implement and manage document control processes, coordinate training for staff, and contribute to the generation of metrics. This role requires technical expertise in quality management systems, organizational skills, creativity, and critical thinking.

KEY ACCOUNTABILITIES 

1. Monitor QMS performance, implement improvements, and troubleshoot issues
2. Manage user accounts, roles, permissions, and access controls within the QMS
3. Provide support to QMS users across departments
4. Generate and analyze quality metrics and reports from the QMS
5. Manage document control processes and workflows
6. Train staff on document control processes
7. Manage training materials and documentation
8. Coordinate with management to identify training priorities
9. Ensure training is appropriately assigned
10. Other project work and responsibilities as required.

KNOWLEDGE, SKILLS & ATTRIBUTES

Essential:

1. 3+ years of Quality experience in a Life Sciences or related field
2. Excellent verbal and written communication skills, including technical writing capability
3. Excellent organizational and time management skills
4. Critical thinking skills, including technical troubleshooting and problem-solving
5. Deep understanding of quality management principles
6. Risk assessment and mitigation abilities
7. Strong presentation and facilitation skills, including ability to explain technical and quality concepts to various audiences
8. Adaptability and willingness to learn new technologies and regulations
9. Self-motivated with the ability to work independently
10. Customer service orientation

Desirable (maximum 5):

1. Experience with validation of computer systems in regulated environments
2. Experience with electronic QMS solutions (Dot Compliance, MasterControl, TrackWise, Veeva, etc.)
3. Knowledge of regulatory requirements for documentation (ISO, FDA, cGMP, etc.)
4. Experience with Learning Management Systems (LMS)

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