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

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

📋 Description

• Perform audits of organizations involved in pharmaceuticals, medical devices, clinical trials, and software development to ensure adherence to regulations concerning computer systems, artificial intelligence, and data integrity.

• Carry out gap assessments and offer guidance for remediation.

• Create and write policies, procedures, and operational instructions.

• Provide counsel to clients on validation of computer systems, compliance with AI regulations, and strategies for data integrity.

• Oversee internal resources implementing client strategies.

• Design and sustain internal protocols and tools for CSV, AI assurance, and data integrity services.

• Generate and present original content, including blogs, training materials, and webinars.

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

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

• Support the creation of marketing and sales materials.

• Participate in business development initiatives.

• Collaborate with Operations on staffing for client projects.

• Conduct interviews for ProPharma candidates.

• Travel as needed.

• Execute additional responsibilities as assigned.

⛳️ Requirements

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

• Certified auditor.

• At least 10 years of experience in auditing.

• A minimum of 30 audits performed in CSV, IT GxP compliance, AI GxP compliance, or electronic data integrity.

• At least 15 years of experience in the pharmaceutical or medical device sector.

• Proficient in English; additional fluency in another EU language is preferred.

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

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

• Basic knowledge of AI use cases and the latest GxP compliance requirements.

• Proven track record of authoring policies and procedures/SOPs.

• Experience in conducting audits and gap assessments.

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

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

• Extensive understanding of FDA, EU, and MHRA GxP regulations, along with supporting ICH and PIC/S documents.

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

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

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

• Some travel required.

🏝️ Benefits

• Support for remote working options.

• Hybrid working model encouraged for new hires located near an office.

• Commitment to being an Equal Opportunity Employer.

• Strong dedication to diversity, equity, and inclusion.

• A safe and empowering work environment.

• Personal review of applications by the recruitment team.

• Results communicated for every application submitted.