Associate Director - Quality System Owner and AI Compliance
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Job Description
Structured overview of role & requirementsAbout This Role
Lead ideation, development, and deployment of AI and GenAI technologies within global Quality organization focused on GxP-regulated processes.
Own AI system lifecycle including roadmap, product backlog, delivery of MVPs, user training, deployment, validation, and operational support to ensure compliance and measurable business impact.
Serve as primary liaison between Quality, tech teams, regulatory, and other functions to ensure scalable, auditable, and continuously improved AI solutions aligned to compliance and strategic initiatives.
Minimum Requirements
15+ years of professional experience with Bachelor's/Master's degree or equivalent in Engineering, Computer Science, Life Sciences, or related fields.
Proven experience delivering digital transformation, AI/ML, automation, or technology solutions in life sciences regulated (GxP) environments.
Strong knowledge of AI compliance, validation, risk management, and GxP regulations in pharmaceutical or similar regulated settings.
Experience working in agile teams, influencing enterprise-wide business outcomes; fluent in English.
Ideal Candidate Profile
Experienced leader capable of driving AI-enabled Quality system transformations ensuring compliance, efficiency, and user adoption in a global regulated setting.
Technical and strategic thinker comfortable translating complex business requirements into validated AI applications and managing cross-functional stakeholder engagement.
Proven operator in regulated pharmaceutical or related life sciences environment with deep understanding of digital, data, analytics, and AI lifecycle management under GxP constraints.
