Senior Technology Quality Auditor

This is a fully remote position, open to applicants in Romania.

📋 Description

• Take the initiative to lead, plan, schedule, execute, and report on a variety of technology audits throughout all stages of Clinical Research.

• Conduct and deliver high-quality audits and audit reports within established timelines and budgets, either independently or with minimal supervision.

• Travel internationally for audit purposes as needed.

• Gather and assess responses to audit findings, following up or escalating inadequate or delayed responses as required to ensure timelines are adhered to and that satisfactory quality responses are obtained and formally documented.

• Serve as a consultative resource for Operations and Quality regarding the implementation of effective CAPAs and the timely escalation of relevant Quality Events when necessary.

• Organize internal global process and system audits across different regions while developing all essential tools such as report templates, checklists, and standard emails.

• Ensure that all necessary audits are conducted and reported in compliance with Parexel QA standards and within set deadlines.

• Review audit reports, responses, and other program deliverables to guarantee consistent high quality.

⛳️ Requirements

• A minimum of 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety or pharmacovigilance, pharmacy, laboratory, or other pertinent areas in life sciences, such as technology or third-party supplier management.

• At least 2 years of experience in quality assurance and auditing, including substantial experience with applicable GxP technology auditing.

• Exceptional knowledge, understanding, and experience of Good Practices (GxPs) along with international, national, and local regulations and laws related to clinical trials and other clinical research.

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for professional development.