Associate Director-Quality System Owner – Batch Release

Lead the end-to-end development, deployment, and lifecycle management of AI and GenAI technologies within global Quality systems to ensure compliant and efficient processes.

Serve as the primary business and technical liaison across multiple functions to ensure AI applications are scalable, auditable, validated, and aligned with GxP and regulatory requirements.

Drive continuous improvement by monitoring AI adoption KPIs, leading forums, supporting audits, training users, and integrating AI into strategic quality initiatives.

15+ years of professional experience with a Bachelor's or Master's degree in Engineering, Computer Science, Life Sciences, or related discipline.

Proven experience delivering digital transformation, AI/ML, automation, or technology solutions in regulated life sciences environments with GxP compliance.

Strong knowledge of AI/ML technologies and their application in quality systems including validation, compliance, and risk management.

Experience working in agile teams and ability to influence enterprise-wide business outcomes; Fluency in English.

Experienced leader capable of managing complex AI technology projects within pharmaceutical Quality environments with measurable impact on compliance and efficiency.

Strong cross-functional collaborator and communicator skilled in translating business needs into technical solutions and managing regulatory documentation and audit readiness.

Strategic thinker focused on AI lifecycle management, continuous improvement, and integration of digital tools into broader Quality and manufacturing initiatives.