Associate Director - Quality System Owner and AI Compliance

Job Purpose -

To lead the ideation, development and deployment of Artificial Intelligence (AI) and Generative AI (GenAI) technologies within the global Quality organization. This role ensures the compliant, harmonized, and value-driven use of AI and associated automation across GxP-regulated processes by acting as both a program lead and operational enabler. This role directs and manages the translation of business requirements into detailed user requirements and plays and active in the technical development, data pipeline, software documentation, validation efforts, user training, deployment and lifecycle management. This position supports users in the adoption of AI tools and ensures that all AI-enabled applications supported in this role meet regulatory, data integrity, and business performance standards. Own the procedures and documents to ensure compliance to regulations and acceptable deployment GxP AI applications for GSC to include audit support, QMS integration, connection to other applicable applications and use of Enterprise AI mass deployed tools such as GiGi and MSFT CoPilot. The role also serves as a key interface between Quality, TECH, Responsible AI other GSC BUs, and other functions to ensure that AI solutions are scalable, auditable, and continuously improved.

Key Responsibilities -

AI System Development, Deployment and Lifecycle Management

• Define and continuously refine the roadmap for the supported system(s) and AI applications to include a product backlog of enhancements and updates.
• Working with process owners, all relevant stakeholders and Tech to translate the business-identified use cases into business requirements for cost and timing estimates and ultimately into user requirements.
• Drive delivery of AI prototypes to prove concepts and demonstrate value.  Lead further refinement of the AI tool to deliver a minimum viable product (MVP) and iterations per the aligned to roadmap while realizing direct efficiency or effort reduction for the business.
• Lead the implementation of AI use cases across Quality domains, ensuring measurable impact on compliance, efficiency, adoption and user experience.
• Serve as business representative for the technology aspects of AI-enabled Quality processes, ensuring compliant and harmonized use of GxP AI applications across GSC.

Compliance & Risk Management

• Ensure AI applications comply with GxP and data integrity requirements by following process and procedures to include but are not limited to Responsible AI, DTMS (Digital & Tech Management System), Computer Software Validation, AI risk and control measures.
• Collaborate with QMS and validation teams to ensure AI tools are appropriately documented, validated, and auditable.
• Ensure the AI risk and control measures are documented and include as part of the software development and lifecycle process to include risk mitigation, AI guardrails and required data inputs for on-going AI model oversight.

Operational Support & Change Enablement

• Support Quality teams during audits and inspections by preparing AI-related documentation, performance monitoring outputs, and FAQ documentation.
• Train and onboard new users, interns, and site Quality Experts on the AI tools and processes supported by this role.
• Generate appropriate audit preparation documentation that could include an audit storyboard, AI compliance information, frequently asked questions, etc.

Performance Monitoring & Continuous Improvement

• Monitor KPIs related to AI adoption, accuracy, and compliance. Analyze trends and provide guidance to sites on reducing errors and achieving targets.
• Lead forums and working groups for supported systems to drive AI process improvements, share best practices, and harmonize implementation across sites.
• Evaluate change requests and product backlog for supported AI systems and assess their impact on business processes, compliance, and user experience.
• Create and define a plan for data based process oversight after the implementation of AI automation.

Cross-Functional Collaboration

• Interface with Responsible AI, Digital & Tech, Business, Regulatory, Data Governance, and Quality Systems & Standards to ensure AI initiatives are integrated and compliant.
• Represent Quality in steering committees, vendor demos, and industry forums to benchmark and shape best practices.
• Support the integration of AI into broader strategic initiatives such as…