Quality Audit Specialist

Careers Signant Health; Center Square (PA); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Signant Health in Blue Bell, PA is seeking a Quality Audit Specialist to lead client, internal, and vendor audits, and to improve audit processes. The role requires strong organizational skills and the ability to interact with all levels of personnel and regulators.

You will host audits end-to-end, prepare documentation, address findings, and ensure compliance with FDA, MHRA, EMA, and ICH guidelines, leveraging our healthcare technology environment. Hybrid work with occasional on-site audits.

Qualifications

• Minimum 3 years of relevant audit experience.
• Comprehensive knowledge of clinical trials processes and regulations.
• Strong ability to analyze issues and propose corrective actions.
• Experience with audits of software/healthcare technology systems.
• Familiarity with 21 CFR Part 11 and eCTAs is desirable.

Responsibilities

• Host client audits from start to finish, including pre-audit prep and post-audit work.
• Improve related audit processes and ensure documentation is in best order.
• Prepare for upcoming audits with evidence, SMEs, and systems.
• Conduct and host audits professionally, applying best practices.
• Ensure audit findings are managed per procedures and addressed.

Skills

Audit management

Regulatory knowledge

FDA/ MHRA / EMA / ICH familiarity

GxP systems understanding

Audit program governance

Critical thinking

Communication with stakeholders

Documentation & record-keeping

Job description

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

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.

Key Accountabilities

• 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.

Knowledge, Skills & Attributes

Essential:

• 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.

Desirable:

• 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 records and signatures.

Why Signant Health?

At Signant Health, your work has real impact. Everything we build, support, and deliver helps advance clinical research and bring new treatments to patients faster — improving lives around the world. Our teams combine science, technology, and operational expertise to solve complex clinical trial challenges, and every role contributes to that mission.

We offer a collaborative, global environment where you can grow your career while working alongside experts across clinical, technology, data, and operations, with opportunities to learn, take ownership, and drive meaningful innovation — not just maintain the status quo.

If you are looking for purpose‑driven work, smart colleagues, and the opportunity to help shape the future of clinical research and digital health, Signant Health is the place to do it.

At Signant Health, accepting difference isn't enough — we celebrate it, we support it, and we nurture it for the benefit of our team members, our clients, and our community. We are proud to be an equal opportunity workplace and an affirmative action employer, committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or veteran status. Prior to their start date, all new hires are required to be verified through a thorough background check and identity verification to confirm eligibility for employment.

Unsolicited resumes submitted by agencies or third‑party recruiters directly to hiring managers or any Signant Health employee will not be considered and will not obligate Signant Health to any fees or terms associated with the submission.