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

Location: Remote based in Serbia, Croatia, Bulgaria or Bosnia; some travel required. Hybrid work may be agreed for employees within a short commute of an office.

Company

hirify.global provides consulting solutions across 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 and gap assessments of pharmaceutical, medical device, clinical, and software organizations covering computer systems, artificial intelligence, and data integrity.
• Provide remediation guidance and advise clients on CSV, AI assurance, and data integrity compliance approaches.
• Author policies, procedures, work instructions, training materials, webinars, and other educational content.
• Manage internal resources, contract personnel, projects, client staffing, and delivery strategies.
• Support business development, marketing and sales materials, practice growth, and candidate interviews.
• Teach CSV, software and AI quality compliance, and data integrity classes as needed.

Requirements

• BSc or higher in life sciences or a related discipline.
• Certified auditor with at least 10 years of auditing experience and 30 or more 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 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 11, EU Annex 11, FDA/EU/MHRA GxP regulations, GAMP5, ANSI standards, ASTM E2500, and data integrity guidance.

Nice to have

• Experience with AI use cases and emerging GxP compliance requirements.
• Proficiency in public speaking through in-person and online forums.

Culture & Benefits

• Remote working support with optional hybrid collaboration for employees near an office.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Environment encouraging innovative, collaborative, and entrepreneurial work.
• Applications are personally reviewed and each applicant receives an outcome.