Quality and Regulatory Affairs Auditor

About the role

The Quality Assurance (QA) department at TransPerfect operates as an independent division that drives continuous improvement of quality standards. As a Quality and Regulatory Affairs Auditor you will influence the Global Quality Management System, ensuring compliance with international and local regulations and standards such as ISO 9001 and ISO 17100. You will work closely with clients, auditors, vendors and internal stakeholders to maintain high levels of customer satisfaction.

Key responsibilities

• Develop and execute audit programs, schedules and ad‑hoc audits in line with ISO 9001, ISO 17100, GxP and other relevant standards.
• Host, manage and coordinate customer audits and qualification activities, including communication of outcomes.
• Investigate audit findings, conduct root‑cause analysis and implement corrective and preventive actions (CAPA) aligned with corporate processes.
• Maintain internal trackers, audit platforms and prepare periodic trend analysis reports for management.
• Support registrar and regulatory inspections, and assist in closure activities as required.
• Collaborate with project teams to resolve audit findings and contribute to continuous improvement of the Quality Management System.

Required profile

• Minimum Bachelor’s degree or equivalent.
• At least two years of experience in Life Sciences QA, including audit, clinical study documentation and eClinical technologies.
• Strong written and verbal communication skills in English.
• Proven ability to manage multiple projects and audits simultaneously in a fast‑paced environment.
• Experience with ISO 9001, ISO 17100 and/or ISO 27001, as well as sponsor and regulatory inspections.

Required skills

• ISO 9001, ISO 17100, ISO 27001 standards.
• GxP, CAPA, change control and deviation management.
• Audit platforms and internal tracking tools.
• Microsoft Office suite.
• Six Sigma and Lean methodologies.
• Lead Auditor certification (preferred).