Clinical Trials Quality Auditor — Remote/Hybrid

Signant Health; Center Square (PA); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Signant Health is seeking a Quality Audit Specialist to manage client audits and internal/vendor audits. The role requires strong organizational skills, cross-functional collaboration, and the ability to interact with clients and regulators.

Hybrid work in Blue Bell, PA with occasional in-office support is expected. The candidate should have at least 3 years in audit, deep regulatory knowledge, and a solid grasp of healthcare technology systems.

Qualifications

• Previous knowledge and experience in audit and inspection management, and management of audit programs.
• Real-world auditing experience as a Quality Auditor.
• Minimum 3 years of relevant audit experience.
• Comprehensive knowledge of clinical trials processes and regulations (FDA/MHRA/EMA) and ICH Guidelines.
• Strong critical thinking to analyze issues and recommend actions.
• Strong understanding of healthcare technology systems.
• Solid computer literacy and ability to work independently in tech-reliant environments.
• Knowledge of governmental regulations impacting clinical research and drug development.
• Flexibility and adaptability in a changing environment with stakeholder management.

Responsibilities

• Host client audits from start to finish, including pre-audit prep and post-audit responsibilities.
• Assist with defining and improving related audit processes.
• Prepare for upcoming audits ensuring documentation and evidence are organized.
• Conduct and host audits professionally and courteously, following best practices.
• Ensure valid audit findings are managed according to procedures.
• Collaborate with management to review and address issues and findings.
• Perform internal and vendor audits as needed.

Skills

Audit management

Quality auditing

Regulatory knowledge

GxP awareness

Stakeholder comms

Education

B.S. in Life Sciences

GCP certification

Tools

Audit software

Documentation tools

Job description

Signant Health is seeking a Quality Audit Specialist to manage client audits and internal/vendor audits. The role requires strong organizational skills, cross-functional collaboration, and the ability to interact with clients and regulators.

Hybrid work in Blue Bell, PA with occasional in-office support is expected. The candidate should have at least 3 years in audit, deep regulatory knowledge, and a solid grasp of healthcare technology systems.