Quality Audit Specialist

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.

Location: Hybrid – Blue Bell, PA (US). Mostly remote; must be local to support client audits at the office on an as‑needed basis.

The Quality Audit Specialist is responsible for managing client audits along with performing internal audits and vendor audits as needed. The candidate must have well‑developed organizational skills and the ability to interact with all levels of personnel, our clients, and potentially regulatory Investigators. The individual must be a self‑starter and results‑oriented, with the ability to articulate, receive, disseminate, and analyze information and documentation, and will be responsible for all aspects of the audit process.

• Host client audits from start to finish, including all pre‑audit preparation and post‑audit responsibilities.
• Assist with defining and improving all related processes within the remit of the role.
• Prepare fully for upcoming audits to ensure all possible documentation, subject matter expertise, systems, and other forms of evidence are fully available and in best order.
• Conduct and host audits professionally and courteously, ensuring best current practices are employed.
• Ensure valid findings from the audit/inspection report are managed effectively by the organization and in accordance with established procedures.
• Collaborate with management to review and address issues and findings.
• Perform internal and vendor audits as needed.

• Previous knowledge and experience in audit and inspection management, and management of audit programs.
• Real‑world auditing experience having worked as a Quality Auditor.
• Minimum 3 years of relevant audit experience.
• Comprehensive knowledge of the clinical trials process and relevant regulations (e.g., FDA, MHRA, EMA) and ICH Guidelines.
• Strong critical thinking skills to analyze complex situations, identify non‑compliant issues, and recommend appropriate corrective and preventive actions.
• Strong understanding of software development and healthcare technology systems.
• Solid computer literacy; able to function independently within a technology‑reliant environment.
• Knowledge of governmental regulations impacting clinical research and drug development.
• Flexibility, open‑mindedness, and adaptability in a rapidly changing environment; able to develop strong working relationships with key stakeholders and manage competing priorities.

• Familiarity with eCOA, IRT, Patient Engagement, Scale Administration, and Rater Training.
• Knowledge of GxP Computerized Systems.
• Demonstrated specific technical knowledge of GCP areas subject to audit.
• Familiarity with 21 CFR Part 11 relating to electronic…