Director of Quality Excellence

Responsibilities

• AI and Automation Strategy for Quality
• Define and own the strategy to scale quality through automation, software-based quality controls, and AI-enabled monitoring, reducing reliance on manual audit headcount.
• Build AI-driven monitoring that flags error signals in real time and surfaces risk patterns before they result in operational or patient-facing errors.
• Partner with Engineering and Product to embed automated quality checks directly into operational systems so quality is enforced at the point of work, not inspected afterward.
• Maintain a forward roadmap for emerging quality capabilities, evaluating new tools and techniques and integrating them into the operating model as they mature.
• Error Prevention and Predictive Quality
• Shift the quality function from detecting errors after they occur to preventing them upstream through process controls, system design, and early-signal monitoring.
• Identify the conditions and process points that produce errors and drive design changes that remove the failure mode rather than catching it later.
• Build predictive indicators that allow the organization to intervene before a defect becomes a realized error.
• Cross-Functional Influence and Accountability
• Own an escalation framework with assigned owners, target resolution dates, and defined escalation paths for every cross-functional quality issue.
• Drive quality issues to resolution across operational partner teams, holding partner leaders accountable to committed timelines.
• Originate and complete cross-functional quality improvement initiatives with documented, measurable outcomes such as error rate reduction or implemented process change.
• Engage partner leadership the moment issues are identified rather than allowing them to persist across review cycles.
• Urgency and Ownership of Execution
• Maintain a live initiative tracker covering milestones, owners, status, and blockers for all active quality projects.
• Deliver staffing models, reporting standardization, and automation roadmaps on committed timelines without requiring repeated direction.
• Escalate blockers quickly with a written proposed path forward, and ensure no initiative stalls without timely escalation.
• Operational Process Mastery
• Maintain deep fluency across the core operational workflows the quality function oversees.
• Lead structured deep-dives and produce data-supported root cause analyses that identify the issue, the root cause, supporting data, and a specific corrective action.
• Independently diagnose error patterns and drivers in executive settings without reliance on prepared summaries.
• Executive Communication and Preparation
• Produce structured pre-reads and prep materials for executive and business reviews.
• Deliver clear, data-driven narratives covering metrics, trends, root cause, actions taken, and open items.
• Independently own leadership communication and delivery to senior operational audiences, including the executive team.
• Leadership and Team
• Lead and develop the quality team across audit, analysis, and quality engineering functions.
• Build reporting infrastructure and quality systems that give leadership real-time visibility into error rates and drivers.
• Partner with Engineering and Product to embed quality monitoring and automated controls into operational platforms.

Qualifications

• Bachelor's degree or equivalent experience
• 10+ years of operational quality, quality engineering, or process excellence experience
• 5+ years owning and scaling a quality function, not solely operating an existing one
• 5+ years managing cross-functional and team-specific initiatives in a matrixed environment
• Demonstrated ability to translate quality strategy into system design, process controls, and operational execution
• Strong analytical and problem-solving skills with a data-driven approach to root cause diagnosis and decision making
• Direct experience shifting a quality operation from manual, after-the-fact auditing toward automated and system-embedded controls
• Familiarity with AI and LLM applications for quality monitoring, anomaly detection, and predictive error prevention
• Demonstrated ownership of software quality assurance for operational or customer-facing platforms, including test automation, release validation, and partnering with Engineering on defect prevention and resolution
• Experience designing quality processes, documentation standards, and scalable operating models that grow coverage without linear headcount growth
• Proven ability to influence stakeholders and drive accountability across teams without direct reporting authority
• Self-motivated and proactive, with a demonstrated bias toward originating work rather than waiting for problems to be framed
• Excellent written and verbal communication skills, with the ability to present data-driven narratives to senior leadership
• Experience in a regulated, high-accuracy environment such as pharmacy, healthcare, or clinical operations preferred
• Ability to travel up to 20%