Associate Director - Digital Solutions Quality Lead

Key Responsibilities

• Co-create in partnership with the function to the Quality digital, data, and AI strategy aligned to enterprise architecture, data strategy, and TGS priorities.
• Define the future-state capability model and an outcome-based roadmap (value, risk reduction, and compliance impact) with Quality process owners.
• Identify, prioritize, and scale high-value use cases across core Quality processes (e.g., field actions, complaints, nonconformances, CAPA, deviations, change control, audits, supplier quality, training, surveillance).
• Own the end-to-end solution vision across core Quality platforms and digital capabilities (e.g., eQMS; Quality data & analytics) to reinvent quality processes and shorten cycle time to compliant outcomes.
• Partner with the digital team and function to ensure context across the digital ecosystem to fully leverage and unlock the power of data assets.
• Provide platform and product direction (roadmaps, lifecycle/modernization, integration, data architecture, AI readiness) in partnership with Platform Solutions/Digital Transformation teams.
• Ensure solutions are scalable, interoperable, and audit-ready across product owners, architects, data teams, and vendors.
• Drive adoption of Quality data models, analytics, and insights to improve decision-making and outcomes.
• Champion advanced analytics and responsible AI (predictive, trend detection, decision intelligence) for regulated use cases and proactive insights to prevent compliance issues.
• Ensure AI/automation and digital solutions meet compliance expectations (validation, data integrity, auditability; GxP/21 CFR Part 11).
• Represent Quality priorities in governance (investment, portfolio, and architecture forums) and facilitate prioritization decisions (risk/value/compliance).
• Provide strategic oversight and value realization for initiatives (execution owned by delivery teams), including benefits tracking and continuous improvement.
• Drive adoption of Quality data models, analytics, and insights to improve decision-making and outcomes.
• Champion advanced analytics and responsible AI (predictive, trend detection, decision intelligence) for regulated use cases and proactive insights to prevent compliance issues.
• Ensure AI/automation and digital solutions meet compliance expectations (validation, data integrity, auditability; GxP/21 CFR Part 11).
• Represent Quality priorities in governance (investment, portfolio, and architecture forums) and facilitate prioritization decisions (risk/value/compliance).
• Provide strategic oversight and value realization for initiatives (execution owned by delivery teams), including benefits tracking and continuous improvement.
• Drive adoption of Quality data models, analytics, and insights to improve decision-making and outcomes.
• Champion advanced analytics and responsible AI (predictive, trend detection, decision intelligence) for regulated use cases and proactive insights to prevent compliance issues.
• Ensure AI/automation and digital solutions meet compliance expectations (validation, data integrity, auditability; GxP/21 CFR Part 11).
• Represent Quality priorities in governance (investment, portfolio, and architecture forums) and facilitate prioritization decisions (risk/value/compliance).
• Provide strategic oversight and value realization for initiatives (execution owned by delivery teams), including benefits tracking and continuous improvement.

Required Qualifications

• Bachelor’s degree or equivalent experience
• 8+ years leading digital and technology solutions in regulated Quality environments
• Demonstrated experience owning digital, data, or platform strategy (not just delivery)
• Strong understanding of Quality systems, Quality compliance expectations, and computerized system controls
• Experience enabling analytics, automation, or AI in regulated environments
• Prowess in the practical use of AI and automation to drive value outcomes with examples of deployment at scale

Preferred Qualifications

• Experience with Quality platforms such as Trackwise, MasterControl, and other eQMS solutions, and analytics platforms
• Experience working with enterprise data platforms, integrations, and reporting tools (e.g., SAP, Power BI, Databricks, integration platforms)
• Familiarity with product-based delivery models, Agile/Hybrid delivery, and platform operating models
• Experience shaping AI governance, validation approaches, and data integrity models
• Global, matrixed operating experience