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

This is a fully remote position, open to applicants in Serbia.

📋 Description

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

• Execute gap assessments and offer remediation guidance to achieve compliance with health authority regulations concerning computer systems, artificial intelligence, and data integrity.

• Draft policies, procedures, and work instructions that comply with health authority regulations relevant to computer systems, artificial intelligence, and data integrity.

• Advise and guide clients on strategies for computer system validation, AI compliance, and data integrity compliance. Oversee internal teams in implementing these strategies.

• Aid in the development and maintenance of internal procedures and tools for delivering CSV, AI assurance, and data integrity services.

• Create and present original CSV content on contemporary topics affecting Computer System Validation, AI compliance, and electronic data integrity, such as blogs, training materials, and webinars.

• Teach classes on computer system validation, software/AI quality compliance, and data integrity as needed.

• Contribute to the formulation of business strategies aimed at expanding ProPharma’s CSV, AI Assurance, and Data Integrity practice.

• Support the development of marketing and sales materials. Participate in business development activities. Assist operations with client project staffing. Conduct interviews for ProPharma Group candidates. Some travel may be required. Perform other duties as assigned.

⛳️ Requirements

• Bachelor’s degree or higher in a life sciences or related field relevant to the role.

• Certified auditor.

• At least 10 years of auditing experience.

• A minimum of 30 audits conducted in one or more of the following areas: Computer System Validation (CSV), IT GxP compliance, AI GxP compliance, and electronic data integrity.

• Minimum of 15 years of experience in the Pharma/Med Device industry.

• Proficiency in English and ideally one additional EU language.

• Experience validating all categories of computer systems, including automation control, laboratory systems, quality management systems, ERPs, clinical trial, and pharmacovigilance applications.

• Familiarity with validating various system delivery models, such as SaaS, PaaS, IaaS, and on-premises solutions.

• Basic understanding of AI use cases and evolving GxP compliance requirements.

• Experience in authoring policies and procedures (SOPs).

• Background in conducting audits and gap assessments.

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

• In-depth knowledge of FDA 21 CFR 11, EU Annex 11, and relevant guidance documents.

• Extensive knowledge of FDA, EU, and MHRA GxP regulations and supporting documents, including those from ICH and PIC/S.

• Expert understanding of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).

• Expert knowledge of Data Integrity guidance documents from organizations like the US FDA, EMA, MHRA, PIC/S, and WHO.

• Proficient in public speaking in both in-person and online settings.

🏝️ Benefits

• We celebrate our differences and aim to create a workplace where everyone can be their authentic selves.

• We are dedicated to promoting diversity, equity, and inclusion.

• Employees are encouraged to express their innovative, collaborative, and entrepreneurial spirits.

• As an Equal Opportunity Employer, we take a holistic approach to provide a safe environment where all employees feel empowered to thrive.