Associate Director Auditor (AI Assurance)

TL;DR

Associate Director Auditor (AI Assurance): Conducting audits of pharmaceutical and medical device organizations with an accent on Computer System Validation (CSV), AI Assurance, and Data Integrity. Focus on ensuring compliance with health authority regulations (FDA, EU, MHRA) and developing strategies for GxP compliance in AI and software systems.

Location: Remote based in Serbia, Croatia, Bulgaria, or Bosnia. Hybrid work is encouraged for those residing near company offices.

Company

hirify.global provides end-to-end consulting solutions to biotech, medical device, and pharmaceutical organizations across the complete product lifecycle.

What you will do

• Conduct audits and gap assessments for pharmaceutical and medical device organizations regarding CSV, AI, and data integrity.
• Author policies, procedures, and work instructions to ensure compliance with health authority regulations.
• Provide strategic advice to clients on AI compliance and CSV approaches, managing internal resource teams.
• Develop internal CSV tools and original content, including blogs, webinars, and training materials.
• Support business development and marketing activities to grow the CSV, AI Assurance, and Data Integrity practice.
• Lead candidate interviews and assist operations in staffing client projects.

Requirements

• BSc or higher in life-sciences or a related discipline.
• Certified auditor with at least 10 years of experience and 30+ audits in CSV, IT GxP, AI GxP, or data integrity.
• Minimum 15 years of experience in the Pharma or Medical Device industry.
• Fluent English (C1); proficiency in another EU language is a plus.
• Expert knowledge of FDA 21 CFR 11, EU Annex 11, GAMP5, and GxP regulations (FDA, EU, MHRA, ICH, PIC/S).
• Experience validating various system delivery models including SaaS, PaaS, IaaS, and On-Prem.

Culture & Benefits

• Support for remote working with a balanced approach to in-person collaboration (hybrid).
• Commitment to diversity, equity, and inclusion, fostering an environment where employees can be their authentic selves.
• Entrepreneurial and collaborative culture that encourages innovation.
• Transparent hiring process with guaranteed outcome notifications for all applicants.