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 of computer system validation, AI assurance and data integrity across the EMEA region. The role is fully remote, based in one of the Eastern European hubs, and focuses on supporting pharmaceutical, medical device, clinical and software development clients.

Key responsibilities

• Conduct audits of pharmaceutical, medical‑device, clinical and software organisations for compliance with health‑authority regulations related to computer systems, artificial intelligence and data integrity.
• Perform gap assessments and deliver remediation guidance to achieve regulatory compliance.
• Author policies, procedures and work instructions aligned with applicable regulations.
• Provide expert advice on computer system validation, AI compliance and data integrity strategies.
• Lead internal teams in delivering CSV, AI assurance and data‑integrity services.
• Develop and deliver original content such as blogs, training materials and webinars on current CSV and AI topics.
• Teach classes on computer system validation, software/AI quality compliance and data integrity as needed.
• Contribute to business development, marketing material creation and staffing of client projects.
• Participate in candidate interviews and occasional travel.

Required profile

• University degree (BSc or higher) in life sciences or a related discipline.
• Certified auditor with a minimum of 10 years of auditing experience.
• At least 30 completed audits in Computer System Validation, IT GxP, AI GxP or electronic data integrity.

Required skills

• Computer System Validation (CSV)
• AI GxP compliance
• Data integrity assurance
• IT GxP compliance
• Auditing and gap‑assessment methodologies