Associate Director - Digital Solutions Quality Lead

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Summary: The Associate Director, Digital Solutions Quality Lead is a senior individual contributor within Technology & Global Services (TGS) accountable for defining and advancing the Quality function’s digital, data, and AI strategy. Partnering closely with Quality leadership and process owners, this role shapes the future-state capability model and an outcome-based roadmap that improves Quality performance, strengthens compliance, and reduces operational risk.

Operating at the intersection of platform leadership, digital product strategy, and data/AI enablement, the role owns the end-to-end solution vision across core Quality platforms (e.g., eQMS) and Quality data and analytics. Success requires influencing cross-functional stakeholders and governance forums to prioritize investment and ensure solutions are scalable, interoperable, and inspection‑ready—meeting validation, data integrity, and auditability expectations—while execution is delivered through aligned product, platform, and delivery teams.

• Co-create in partnership with the function 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.
• Support audits/inspections and continuously improve control/validation approaches to enable agile, data‑driven delivery and manage risk in the use of AI/automation.

• 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
• Proven ability to influence senior stakeholders without direct authority
• High proficiency in the practical use of AI and automation to drive value outcomes with examples of…