Associate Director - Auditor - Computer System Validation, AI Assurance, Data Integrity (AI)

Location: Remote from Serbia, Croatia, Bulgaria, or Bosnia; hybrid work may be encouraged for hires within a reasonable commute of an office. Some travel is required.

Company

hirify.global provides consulting and operational expertise in regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Conduct audits of pharmaceutical, medical device, clinical, and software development organizations covering computer systems, artificial intelligence, and electronic data integrity.
• Perform gap assessments and provide remediation guidance aligned with health authority regulations.
• Advise clients on computer system validation, AI compliance, and data integrity approaches while managing internal and contract resources.
• Author policies, procedures, work instructions, training materials, webinars, and other CSV and AI compliance content.
• Teach relevant CSV, software and AI quality compliance, and data integrity classes.
• Support practice strategy, marketing and sales materials, business development, project staffing, and candidate interviews.

Requirements

• BSc or higher in life sciences or a related discipline.
• Certified auditor with at least 10 years of auditing experience and at least 30 audits in CSV, IT GxP compliance, AI GxP compliance, or electronic data integrity.
• At least 15 years of experience in the pharmaceutical or medical device industry.
• Fluent English is required. An additional EU language is desirable.
• Experience validating automation control, laboratory, quality management, ERP, clinical trial, and pharmacovigilance systems across SaaS, PaaS, IaaS, and on-premises models.
• Expert knowledge of FDA 21 CFR Part 11, EU Annex 11, FDA, EU and MHRA GxP regulations, ICH, PIC/S, GAMP5, ANSI standards, ASTM E2500, and data integrity guidance.

Culture & Benefits

• Remote work is supported from specified Eastern European hubs.
• Hybrid work is encouraged for employees located near an office, subject to agreement with the manager.
• Some travel is required for client and business activities.
• Inclusive workplace focused on diversity, equity, inclusion, collaboration, innovation, and entrepreneurship.
• Applications are personally reviewed and candidates receive an outcome.