Associate Director – Auditor – Computer System Validation, AI Assurance & Data Integrity

About the role

ProPharma is expanding its Compliance and Quality Assurance team with a senior auditor who will lead audits across the EMEA region. The role is fully remote and can be based in Serbia, Croatia, Bulgaria or Bosnia. You will advise biotech, medical‑device and pharmaceutical clients on Computer System Validation, AI assurance and data integrity.

Key responsibilities

• Conduct audits of pharmaceutical, medical‑device, clinical and software development organisations for compliance with health‑authority regulations.
• Perform gap assessments and deliver remediation guidance for CSV, AI GxP and data‑integrity requirements.
• Author policies, procedures and work instructions aligned with regulatory standards.
• Provide expert advice on validation, AI compliance and data‑integrity strategies.
• Manage internal audit teams and support business‑development activities.
• Develop and deliver original content (blogs, webinars, training) on CSV, AI assurance and electronic data integrity.
• Participate in the growth strategy of ProPharma’s CSV, AI Assurance and Data Integrity practice.

Required profile

• BSc or higher in life‑sciences or a related discipline.
• Certified auditor.
• Minimum 10 years of auditing experience, with at least 30 audits in CSV, IT GxP or AI GxP.

Required skills

• Computer System Validation (CSV)
• AI assurance / AI GxP compliance
• Data integrity compliance
• IT GxP compliance

What we offer

• Permanent contract with remote work flexibility.
• Opportunity to shape a newly created practice area.
• Collaborative international team focused on high‑impact regulatory projects.