GSK
Bengaluru, Karnataka, India Posted Oct 26
To lead the ideation, development and deployment of Artificial Intelligence and Generative AI technologies within the global Quality organization at GSK. 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.
Key Responsibilities
1. 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 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.
2. 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, 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.
3. 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.
4. 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.
Requirements
15+ years’ experience with demonstrated experience in delivering Digital Transformation, AI/ML, scaled automation, technology solutions or similar roles within life sciences regulated industries.
Proven leadership in deploying Innovative solutions in highly regulated GxP environments.
Strong experience in technical or engineering role.
Experience working in agile teams that drive innovation and simplification by providing enterprise-wide standardized solutions.
Ability to work across an enterprise to influence business outcomes as quickly as possible.
Deep understanding of Digital, Data, Analytics AI/ML, GenAI, and their application in Quality systems.
Strong knowledge of validation, compliance, and risk management in pharmaceutical settings.
Strong knowledge of business case creation and realization of value from digital project implementation.
Excellent communication, stakeholder engagement, and change management skills.
