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

This is a fully remote position, open to applicants in Croatia, +3 more states.

📋 Description

• Perform audits of pharmaceutical, medical device, clinical, and software development firms to ensure compliance with health authority regulations related to computer systems, artificial intelligence, and data integrity.

• Carry out gap analyses and offer remediation recommendations.

• Draft policies, procedures, and work instructions.

• Provide guidance to clients on approaches for computer system validation, AI compliance, and data integrity adherence.

• Oversee internal resources implementing these strategies.

• Create and sustain internal procedures and tools for CSV, AI assurance, and data integrity services.

• Develop and present original CSV content, such as blogs, training materials, and webinars.

• Deliver training on computer system validation, software/AI quality compliance, and data integrity as required.

• Engage in the development of business strategies for the CSV, AI Assurance, and Data Integrity practice.

• Contribute to the creation of marketing and sales materials.

• Support business development initiatives.

• Assist Operations with staffing for client projects.

• Conduct interviews for ProPharma Group candidates.

• Travel as necessary.

• Execute additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree or higher in life sciences or a related field.

• Certified auditor.

• At least 10 years of auditing experience.

• A minimum of 30 audits conducted in Computer System Validation, IT GxP compliance, AI GxP compliance, or electronic data integrity.

• Minimum of 15 years of experience in the pharmaceutical or medical device industry.

• Proficiency in English and preferably one additional EU language.

• Experience in validating automation control, laboratory, quality management, ERP, clinical trial, and pharmacovigilance systems.

• Familiarity with validating SaaS, PaaS, IaaS, and on-premises delivery models.

• Basic understanding of AI use cases and emerging GxP compliance standards.

• Proven experience in authoring policies, procedures, and SOPs.

• Background in conducting audits and gap analyses.

• Experience managing internal staff, contract resources, and projects.

• In-depth knowledge of FDA 21 CFR 11 and EU Annex 11.

• Comprehensive understanding of FDA, EU, and MHRA GxP regulations and related ICH and PIC/S documents.

• Expert-level knowledge of GAMP5, ANSI S-95, ANSI S-88, and ASTM E2500.

• Extensive knowledge of data integrity guidelines from the US FDA, EMA, MHRA, PIC/S, and WHO.

• Strong public speaking skills in both in-person and online settings.

• Some travel is required.

🏝️ Benefits

• Support for remote work.

• Hybrid work is encouraged for employees within a reasonable commuting distance to an office.

• Commitment to diversity, equity, and inclusion.

• Equal Opportunity Employer.

• A safe and empowering workplace.

• Applications are personally reviewed by the recruitment team.

• Applicants receive feedback on their application status.