Role Purpose

The Quality Audit Specialist is responsible for managing client audits as well as performing internal and vendor audits as needed. This individual must possess strong organizational skills and the ability to interact with all levels of personnel, clients, and potentially regulatory investigators. The role requires a self-starter who is results-oriented and adept at articulating, analyzing, and disseminating information across the audit process.

Key Accountabilities

• Lead remote and in-person client audits, including pre-audit preparation and post-audit responsibilities.
• Support continuous improvement efforts by refining audit-related processes.
• Prepare for audits by ensuring all necessary documentation, systems, and evidence are in place.
• Conduct audits using professional standards and best practices.
• Ensure that valid audit findings are managed in accordance with internal procedures.
• Collaborate across teams to resolve findings and drive quality improvements.
• Perform internal and vendor audits as assigned.

Knowledge, Skills & Attributes

Essential:

• Minimum 3 years of relevant auditing experience.
• Strong understanding of clinical trials processes and regulatory guidelines (e.g., FDA, MHRA, EMA, ICH).
• Experience managing audits and audit programs.
• Strong analytical and critical thinking skills.
• Familiarity with healthcare or software development systems.
• Solid technical proficiency in using digital tools and working independently in a technology-driven environment.
• Knowledge of regulations impacting clinical research and drug development.
• Flexibility and ability to manage competing priorities.

Desirable:

• Experience with eCOA, IRT, Patient Engagement, Scale Administration, Rater Training.
• Understanding of GxP Computerized Systems.
• Knowledge of GCP audit areas and 21 CFR Part 11 (electronic records and signatures).
• Bachelor’s degree and experience in the pharmaceutical industry preferred.