Associate Director – Auditor – Computer System Validation & AI Assurance

About the role

ProPharma is expanding its Compliance and Quality Assurance team with a senior auditor who will lead audits of computer systems, artificial intelligence and data integrity across pharmaceutical, medical device, clinical and software development organisations in the EMEA region. The role is remote‑based in one of our Eastern European hubs.

Key responsibilities

• Conduct audits and gap assessments for compliance with health‑authority regulations covering Computer System Validation (CSV), AI GxP and electronic data integrity.
• Author policies, procedures and work instructions aligned with regulatory requirements.
• Provide remediation guidance and strategic advice to clients on CSV, AI assurance and data integrity.
• Manage internal audit teams and support staffing of client projects.
• Develop and deliver original content such as blogs, training materials, webinars and classroom teaching.
• Contribute to business development, marketing, and growth strategies for the 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, AI GxP or electronic data integrity.

Required skills

• Computer System Validation (CSV)
• AI assurance / AI GxP compliance
• Electronic data integrity
• GxP compliance auditing

What we offer

• Permanent contract with remote work flexibility.
• Opportunity to shape a newly created practice area within a global consulting firm.
• Exposure to leading pharmaceutical, medical‑device and clinical clients.