Senior Quality Assurance Auditor

TL;DR

Senior Quality Assurance Auditor: Leading advanced quality audits and assessments of hirify.global’s procedures, systems, and data to ensure regulatory compliance and high standards of service delivery with an accent on Good Clinical Practices, ISO standards, and risk management. Focus on developing audit plans, overseeing mitigation of observations, and supporting continuous improvement programs.

Location: Remote (Hungary)

Company

hirify.global is a company focused on transforming lives by unlocking better evidence in clinical research.

What you will do

• Perform internal/supplier audits, quality reviews, and gap analyses of operational and technical departments, processes, and systems.
• Manage multiple QA tasks in parallel, prioritize effectively, and coordinate intra/interdisciplinary personnel.
• Act in a leadership role for joint department/supplier auditing efforts, developing audit plans and reviewing reports from other QA Auditors.
• Oversee the mitigation and closure of observations by conducting proactive follow-up with applicable departments.
• Act as host for client audits, liaising between hirify.global and clients, and ensuring successful outcomes.
• Support the Continuous Improvement Program through effective investigation of issues, facilitation of root cause analysis, and management of actions.

Requirements

• College Degree in Health/Life Sciences.
• 5-7 years’ experience in a Quality Assurance capacity with a focus on GCPs and previous auditing experience.
• Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485, and applicable regulatory authorities.
• Excellent leadership, analytical, organizational, and communication skills.
• Competence in Microsoft Office, especially spreadsheets, database, and reporting tools.
• Ability and willingness to travel at least 10-15% of the time (international and domestic).

Culture & Benefits

• Competitive compensation and incentives.
• Private medical coverage and MetLife protection.
• SZÉP Card and telework reimbursement.
• Flexible time off.
• Engaging employee events and hybrid technology support.