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Job Description

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.

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.

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

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

• Proven ability to influence senior stakeholders without direct authority

• High proficiency in the practical use of AI and automation to driv