Hybrid 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

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.